<p><strong><u>Quality Management Systems Engineer (QMS Engineer) – Smyrna, TN</u></strong></p><p><br></p><p>Skills/Requirements:</p><ul><li>Previous Quality Management Systems experience within the automotive industry </li><li>Certification as ISO/IATF16949 </li><li>5+ years experience in the quality assurance field </li><li>2+ years experience in ISO/TS16949 Implementation </li><li>Prior experience working with Third Party Registrars</li></ul><p><br></p><p>Job Description </p><ul><li>Manage and lead all activities associated with the creation, implementation and maintenance of the ISO9001 IATF16949 Quality System</li><li>Ensure training is provided to all personnel within the organization for ISO 9001 / IATF16949 System Requirements </li><li>Facilitate the integration of UES Quality Standards into the QMS </li><li>Promote the company quality policy and the organizational goals of the company </li><li>Assist all areas/departments as needed in developing procedures, work instructions and required documentation </li><li>Coordinate all activities associated with the third party registrar, pre-assessment, initial and surveillance audits </li><li>Ensure that all corrective actions related to non-conformances identified in a third party audit are addressed, processed and verified</li><li>Ensure that the internal audit schedule reviews all elements of the QMS and UES Quality Standards and confirm that the QMS is effectively implemented; Establish firm resolution of internal findings </li><li>Ensure QMS training of all internal auditors and potential corrective action assignees is complete and effective </li><li>Lead the maintenance of the QMS software system and provide technical support </li><li>Audit the effectiveness of root cause analysis of CARs; Provide leadership in the development and implementation of irreversible countermeasures </li><li>Evaluate QMS countermeasures for effectiveness prior to presentation to customer or other auditor </li><li>Participate in Customer audits as required, as well as nonconformance closure activities </li><li>Develop and administer layered process auditing within Portland and Smyrna facilities </li><li>Maintain quality tracking charts as requested </li><li>Prepare necessary metrics, reporting, and presentations for Quality Meetings </li><li>Enter requisitions as needed for PO creation</li></ul><p> </p>

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Quality Engineer (QMS Engineer)

<h1><strong>Job Title: Quality Engineer - NPI</strong></h1><p><strong><em>For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.comwith the following:</em></strong></p><p><strong>1) Word copy of resume</strong></p><p><strong>2) 2-3 professional references</strong></p><p><strong>3) 4-5 brief bullet points highlighting technical qualifications</strong></p><p><br></p><h2>Job Description</h2><p>In this role, you will lead the design for manufacture and assembly by providing technical leadership and guidance in quality assurance, quality control, and preventative activities. You will support the development and introduction of new products, processes, and technologies with a focus on quality systems development, regulatory compliance, and process risk management. Your role involves developing and characterizing processes that are capable, scalable, and produce high yield, while also designing robust inspection strategies.</p><p><br></p><h2>Responsibilities</h2><ul><li>Foster collaborative internal and external professional relationships across design divisions and functions related to design transfer activities.</li><li>Communicate effectively with internal customers, stakeholders, and project teams to ensure successful project transfers.</li><li>Mentor other groups on design and process transfer expertise.</li><li>Develop and implement methods for process control and improvement to ensure product quality.</li><li>Collaborate with suppliers to address quality issues and contribute to supplier quality improvement programs.</li><li>Manage risk by employing risk management practices and tools, with a focus on failure modes and process controls.</li><li>Ensure compliance with ISO14971 standards and support the design team in risk identification and mitigation.</li><li>Develop and implement lean inspection strategies and lead continuous improvements in inspection methods.</li><li>Lead and approve validation strategies and influence processes towards validation.</li><li>Apply statistical techniques to develop robust quality systems and provide expertise for non-conformances and corrective actions.</li><li>Lead supplier qualification strategies and support the implementation of supplier certification.</li><li>Represent quality assurance in design transfer processes and ensure product launches meet established targets.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in risk management and PFMEA</li><li>Experience with validation and quality engineering in medical devices</li><li>Knowledge of ISO14971 and design transfer processes</li><li>Bachelor of Science in Engineering or related field with 3-5 years of experience in a quality or technical discipline</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in developing inspection strategies and using measurement system analysis (MSA)</li><li>Knowledge in CQA and CTQ processes</li><li>Ability to overhaul production processes and align procedures</li></ul><h2>Work Environment</h2><p>This position requires working onsite. The role is an individual contributor position that requires independent work with minimal supervision. Standard benefits are offered, including 2 weeks of PTO and 10 paid holidays.</p>

Quality Engineer - NPI

<h1><strong>Job Title: Quality Engineer - NPI </strong></h1><p><br></p><h2>Job Description</h2><p>As a Quality Engineer specializing in New Product Introduction (NPI), you will advocate and lead design for manufacture and assembly, focusing on quality assurance, quality control, and preventative activities. You will support the development and introduction of new products, processes, and technologies with an emphasis on quality systems development, regulatory compliance, and process risk management.</p><p><br></p><h2>Responsibilities</h2><ul><li>Foster collaborative relationships across Design Divisions, Advanced Operations, and GQO functions associated with design transfer activities.</li><li>Communicate effectively with internal customers, stakeholders, and project teams to deliver successful project transfers meeting NPI project goals.</li><li>Mentor other groups on design and process transfer expertise.</li><li>Develop and implement methods for process control, improvement, testing, and inspection to ensure products are flawless and function as designed.</li><li>Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality and minimize defects.</li><li>Collaborate with supplier representatives on quality issues and contribute to supplier quality improvement programs.</li><li>Proficiently manage risk practices and tools, focusing on production and production-related processes (PFMEA).</li><li>Support the Risk Management File through risk Management Principles.</li><li>Ensure compliance with ISO14971 and support design team in completing CQA/CTQ identification.</li><li>Develop and implement lean inspection strategies and plans through advanced inspection methods and technologies.</li><li>Lead continuous improvements of inspection methods and sampling plans.</li><li>Lead First Article Inspection strategies and approve First Article Inspections.</li><li>Optimize inspection costs while maintaining product safety, integrity, and reliability.</li><li>Support validation strategies for highly capable processes resulting in high yield and scalability.</li><li>Apply statistical techniques to ensure the development of robust, predictive quality systems.</li><li>Provide expertise for NC&#39;s &amp; CAPA&#39;s related to new products.</li><li>Lead supplier qualification strategy and approve supplier validations and Production Part Approval Process (PPAP).</li><li>Represent quality assurance during the Design Transfer Agreement Plan (DTAP) process.</li><li>Participate in internal &amp; external audits with regulatory representatives.</li><li>Represent NPI Quality Assurance at Design reviews and ensure integrity of process design.</li><li>Support device design into production specifications.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor of Science, Engineering or related subject with 3-5 years’ experience in a quality or technical discipline.</li><li>Proficiency in ISO standards, Design Transfer, Manufacturing, Risk Management, and PFMEA.</li><li>Experience in Validation, Quality Engineering, Medical Devices, Design Control, and Product Transfer.</li><li>Strong understanding of CQA, CTQ, ISO14971, MSA, and PFMEA.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Good experience in overhauling production processes, including MVPs, PFMEAs, value stream maps, and procedure alignment.</li></ul><h2>Work Environment</h2><p>This role is based onsite, providing a collaborative and dynamic work environment. Employees enjoy benefits such as 2 weeks of PTO, 10 paid holidays, and standard benefits.</p>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>We are seeking a dedicated Quality Engineer to oversee investigations into customer complaints, execute root cause analysis, and conduct testing of returned products to understand and resolve issues. This role will involve collaboration with the R&amp;D team to identify effective solutions.</p><br><h2>Responsibilities</h2><ul><li>Investigate customer complaints regarding product issues.</li><li>Conduct root cause analysis and testing protocols to determine underlying problems.</li><li>Open returned products for thorough examination and testing.</li><li>Document findings and communicate results to the engineering team.</li><li>Monitor ongoing customer complaints and ensure proper documentation.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in conducting investigations and root cause analysis.</li><li>Experience with product testing and complaint documentation.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience with NCR (Non-Conformance Report) and CAPA (Corrective and Preventive Action) processes.</li><li>Familiarity with document control procedures.</li></ul><h2>Work Environment</h2><p>Join a dynamic team developing FDA-cleared, minimally invasive therapeutic devices using temperature-controlled radiofrequency energy. Our focus is on treating chronic nasal conditions such as nasal airway obstruction and chronic rhinitis. Work involves collaboration with R&amp;D in a supportive and innovative environment.</p><br>

Quality Engineering "Part Time"

<p><strong>Description</strong></p>
					<p>•	Set goals, monitor progress, and ensure accountability for teams and individual members
•	Accountable for managing resources to ensure key quality department metrics are met
•	Collaborate with internal and external customers’ quality and engineering personnel to determine critical part features and review manufacturability of design
•	Make recommendations to modify customer part specifications and tolerances as necessary to support cost effective production
•	Provide engineering support to operations ensuring consistent application of quality techniques
•	Resolve quality issues by identifying problems, examining solution options, implementing action plans, and providing resources
•	Effectively communicate and reinforce company commitment to quality improvement efforts
•	Determine when process stability and capability studies should be performed on existing processes. Review and analyze results. Recommend changes to processes based upon findings and perform follow up to verify effectiveness
•	Participate and coordinate with other department (i.e.: Engineering, Manufacturing Engineering, Purchasing, Tooling, Operations, etc.) product Quality planning activities to determine appropriate use of existing and new systems
•	Facilitate and promote use of appropriate problem-solving techniques for effective root cause analysis and successful corrective action
•	Participate directly in internal and external customer PPM improvement plan
•	Responsible and accountable to the performance of the Quality team/group</p>
					<p><strong>Skills</strong></p>
					<p>Quality engineering, APQP, advanced planning, PAPP, black belt, green belt</p>
					<p><strong>Top Skills Details</strong></p>
					<p>Quality engineering,APQP,advanced planning,PAPP</p>
					<p><strong>Additional Skills &amp; Qualifications</strong></p>
					<p>MUST be proficient with APQP</p>
					<p><strong>Experience Level</strong></p>
					<p>Expert Level</p>

Quality Engineering Manager

<h1><strong>Job Title: Quality Engineering Technician</strong></h1><p><br></p><h2>Job Description</h2><p>The primary objective of this role is to ensure quality in manufacturing and supply chain in support of the development and production of the driver, delivering the benefits of self-driving technology safely, quickly, and broadly. A successful candidate understands quality processes, possesses strong attention to detail, has a quality-focused mindset, and can contribute to cross-functional teams to identify and eliminate quality problems, issues, and risks.</p><p><br></p><h2>Responsibilities</h2><ul><li>Lead and support inspection and test plan creation in coordination with engineering.</li><li>Provide guidance related to part inspection and test procedures.</li><li>Perform inspections (first article, incoming, in-process, outgoing) according to inspection plans and procedures to record, analyze data, document, and report results.</li><li>Perform tests (qualification, incoming, in-process, end-of-line) according to test plans and procedures to record, analyze data, document, and report results.</li><li>Conduct physical inspections using various gauges, tools, and inspection equipment.</li><li>Perform dimensional and gauge studies (MSA, R&amp;R) in coordination with engineering.</li><li>Carry out cable and harness assembly testing and troubleshooting.</li><li>Perform soldering and wire splicing inspections.</li><li>Assemble electromechanical modules.</li><li>Execute inventory physical and electronic transactions as needed.</li><li>Operate inspection and test fixtures or equipment, with the ability to train others as required.</li><li>Assist in training manufacturing teams and technicians on in-process inspections and/or tests.</li><li>Support activities related to non-conforming product(s) and returned material authorization activities (Material Review Board).</li><li>Participate in layered audit and manufacturing process audit activities.</li><li>Actively engage in continuous improvement activities.</li><li>Follow and support company safety requirements, policies, procedures, and work instructions.</li><li>Adhere to written, verbal, and visual instructions.</li><li>Perform other duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Quality assurance expertise in automotive manufacturing and electro-mechanical assembly operations.</li><li>3+ years of experience in quality automotive manufacturing, robotics, or equivalent field.</li><li>Proficiency in debugging complex electronic assemblies and manufacturing cable assemblies.</li><li>Experience with CNC mills, lathes, and other machine shop tools.</li><li>Understanding of electrical and mechanical drawings.</li><li>Proficient in using various gauges, measuring devices, and equipment.</li><li>Experience with Linux operating systems.</li><li>Experience with Google Sheets, Docs, Slides, and Gmail.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>An Associate Degree, Technician Certificate, or equivalent in engineering/photonics/lasers/electro-optics.</li><li>IPC 610 and IPC 620 certifications.</li><li>Attention to detail and careful handling of precision components and equipment.</li></ul><h2>Work Environment</h2><p>This is an on-site position with meals provided.</p>

Quality Engineering Technician

<h1><strong>Quality Engineering Technician</strong></h1><p><br></p><h2>Job Description</h2><p>The primary objective of this role is to ensure quality in manufacturing and supply chain in support of the development and production of the driver, delivering the benefits of self-driving technology safely, quickly, and broadly. A successful candidate understands quality processes, possesses strong attention to detail, has a quality-focused mindset, and can contribute to cross-functional teams to identify and eliminate quality problems, issues, and risks.</p><p><br></p><h2>Responsibilities</h2><ul><li>Lead and support inspection and test plan creation in coordination with engineering.</li><li>Provide guidance related to part inspection and test procedures.</li><li>Perform inspections (first article, incoming, in-process, outgoing) according to inspection plans and procedures to record, analyze data, document, and report results.</li><li>Perform tests (qualification, incoming, in-process, end-of-line) according to test plans and procedures to record, analyze data, document, and report results.</li><li>Conduct physical inspections using various gauges, tools, and inspection equipment.</li><li>Perform dimensional and gauge studies (MSA, R&amp;R) in coordination with engineering.</li><li>Carry out cable and harness assembly testing and troubleshooting.</li><li>Perform soldering and wire splicing inspections.</li><li>Assemble electromechanical modules.</li><li>Execute inventory physical and electronic transactions as needed.</li><li>Operate inspection and test fixtures or equipment, with the ability to train others as required.</li><li>Assist in training manufacturing teams and technicians on in-process inspections and/or tests.</li><li>Support activities related to non-conforming product(s) and returned material authorization activities (Material Review Board).</li><li>Participate in layered audit and manufacturing process audit activities.</li><li>Actively engage in continuous improvement activities.</li><li>Follow and support company safety requirements, policies, procedures, and work instructions.</li><li>Adhere to written, verbal, and visual instructions.</li><li>Perform other duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Quality assurance expertise in automotive manufacturing and electro-mechanical assembly operations.</li><li>3+ years of experience in quality automotive manufacturing, robotics, or equivalent field.</li><li>Proficiency in debugging complex electronic assemblies and manufacturing cable assemblies.</li><li>Experience with CNC mills, lathes, and other machine shop tools.</li><li>Understanding of electrical and mechanical drawings.</li><li>Proficient in using various gauges, measuring devices, and equipment.</li><li>Experience with Linux operating systems.</li><li>Experience with Google Sheets, Docs, Slides, and Gmail.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>An Associate Degree, Technician Certificate, or equivalent in engineering/photonics/lasers/electro-optics.</li><li>IPC 610 and IPC 620 certifications.</li><li>Attention to detail and careful handling of precision components and equipment.</li></ul><h2>Work Environment</h2><p>This is an on-site position with meals provided.</p>

<h1 style="font-weight: 700;">Job Title: Quality Engineering Technician</h1><br><h2>Job Description</h2><p>As a Quality Engineering Technician, you will be responsible for conducting thorough inspections of Uninterruptible Power Supply (UPS), Lithium-Ion Battery Cabinets, and other AC Power products throughout the manufacturing process. You will ensure that all AC power-related components meet design specifications, electrical codes, and internal quality standards prior to the Testing phase. This role is crucial in identifying defects, verifying safety compliance, and supporting root-cause analysis for continuous improvement.</p><br><h2>Responsibilities</h2><ul><li>Inspect assembled UPS units and subcomponents, such as inverters, rectifiers, transformers, and bypass switches, for electrical and mechanical conformity.</li><li>Review blueprints, schematics, and technical diagrams against physical builds.</li><li>Conduct inspections of AC power products including wiring, grounding, and busing against workmanship standards.</li><li>Evaluate proper torquing, cable routing, labeling, and hardware stack ups in accordance with layout diagrams.</li><li>Document all findings and discrepancies in quality records and inspection checklist.</li><li>Tag nonconforming units and coordinate with production and engineering to resolve issues.</li><li>Participate in root cause analysis and corrective action implementation for recurring defects or process deviations.</li><li>Collaborate with production line leads and assemblers to promote build quality and safety practices.</li><li>Consult Oracle/PD Cloud or the current operating system for part revision numbers, location and availability of parts, quantity of parts, engineering changes, etc.</li></ul><h2>Essential Skills</h2><ul><li>3-5 years of Quality Technician Experience.</li><li>Strong understanding of AC power systems and UPS design principles.</li><li>Ability to interpret electrical schematics, wiring diagrams, and mechanical drawings.</li><li>Excellent attention to detail and documentation skills.</li><li>Basic computer proficiency in MS Office, Oracle EBS, Outlook, PowerPoint, CAD.</li><li>Strong communication skills and ability to work cross-functionally with production, quality, and engineering teams.</li><li>Knowledge of ISO 9001 standards, specifically with Product Planning and Verification Clauses.</li><li>Experience in lean manufacturing concepts, continuous improvement, and/or Six Sigma methods.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Familiarity with torque wrenches, multi-meters, and calibers.</li><li>Knowledge of electrical systems and components.</li></ul><h2>Work Environment</h2><p>This role is based in a manufacturing work environment, with first shift hours from 6 am to 2:30 pm. Overtime will be required, potentially on Saturdays as well. The position is a long-term contract to hire, initially for 9 months. The facility is equipped with advanced tools and technologies to support your work.</p><br>

<h1 style="font-weight: 700;">Job Title: Quality Engineering Technician</h1><br><h2>Job Description</h2><p>The Quality Engineering Technician is responsible for conducting detailed inspections of Uninterruptible Power Supply (UPS), Lithium-Ion Battery Cabinets, and other AC Power products throughout the manufacturing process. This role ensures all AC power-related components meet design specifications, electrical codes, and internal quality standards before entering the Testing phase. The technician plays a pivotal role in identifying defects, verifying safety compliance, and supporting root-cause analysis for continuous improvement.</p><br><h2>Responsibilities</h2><ul><li>Inspect assembled UPS units and subcomponents such as inverters, rectifiers, transformers, and bypass switches for electrical and mechanical conformity.</li><li>Review blueprints, schematics, and technical diagrams against physical builds.</li><li>Conduct inspections of AC power products, including wiring, grounding, and busing against workmanship standards.</li><li>Evaluate proper torquing, cable routing, labeling, and hardware stack ups in accordance with layout diagrams.</li><li>Document all findings and discrepancies in quality records and inspection checklists.</li><li>Tag nonconforming units and coordinate with production and engineering to resolve issues.</li><li>Participate in root cause analysis and corrective action implementation for recurring defects or process deviations.</li><li>Collaborate with production line leads and assemblers to promote build quality and safety practices.</li><li>Consult Oracle/PD Cloud or the current operating system for part revision numbers, location and availability of parts, quantity of parts, and engineering changes.</li></ul><h2>Essential Skills</h2><ul><li>3-5 years of Quality Technician experience.</li><li>Inspection, Engineering, Troubleshooting, Quality engineering, Quality control, Quality assurance.</li><li>Electronics and Mechanical knowledge.</li><li>Strong understanding of AC power systems and UPS design principles.</li><li>Ability to interpret electrical schematics, wiring diagrams, and mechanical drawings.</li><li>Excellent attention to detail and documentation skills.</li><li>Basic computer proficiency in MS Office, Oracle EBS, Outlook, PowerPoint, CAD.</li><li>Strong communication skills and ability to work cross-functionally with production, quality, and engineering teams.</li><li>Knowledge of ISO 9001 standards, specifically with Product Planning and Verification Clauses.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experienced in lean manufacturing concepts, continuous improvement, and/or Six Sigma methods.</li><li>Familiarity with torque wrenches, multi-meters, and calibers.</li></ul><h2>Work Environment</h2><p>The position is set in a manufacturing work environment. It offers a long-term contract with the potential to transition to a permanent role after nine months.</p><br>

<h1><strong>Job Title: Quality Environmental Monitoring Specialist</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a dedicated and detail-oriented Quality Environmental Monitoring Specialist. This role is pivotal in maintaining the cleanliness and compliance of our cleanrooms and controlled areas through rigorous environmental monitoring and documentation practices.</p><p><br></p><h2>Responsibilities</h2><ul><li>Perform environmental monitoring of cleanrooms and controlled areas, including viable air, non-viable particles, critical surface monitoring, and personnel monitoring.</li><li>Collect routine environmental samples from surfaces, air, and water.</li><li>Maintain accurate and complete documentation of sampling information and results in compliance with Good Documentation Practices (GDP).</li><li>Label environmental samples appropriately and submit them to the laboratory via LIMS.</li><li>Submit finished good products for additional testing.</li><li>Review and perform trending on environmental monitoring results.</li><li>Assist with investigations related to out-of-specification (OOS) results, excursions, or contamination events.</li><li>Adhere to internal quality procedures related to proper gowning, hygiene, and microbial control to maintain cleanliness within cleanrooms.</li><li>Assist in the development and implementation of processes, reports, data analysis, and procedures within the defined area of specialization.</li><li>Perform audits to review related documentation for completeness, accuracy, and ensure the product and reports meet all specifications.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>High school graduate or GED required</li><li>Associate or bachelor’s degree in biology, microbiology, or a science-related field preferred</li><li>0 to 2 years of work experience within a manufacturing environment, with GMP experience preferred</li></ul><p><br></p>

Quality Environmental Monitoring Specialist

<h1><strong>Quality Hygienist</strong></h1><p><br></p><h2>Job Description</h2><p>As a Quality Hygienist, you will play a crucial role in protecting the safety and quality of our product. You will be responsible for maintaining pre-requisite components of the Food Safety Management System by establishing, maintaining, and coaching the building blocks of hygiene and food safety concepts in the manufacturing facility. Your expertise in hygiene and sanitation will be essential to maintaining the highest standards for our environment and products. You will also be responsible for identifying and addressing potential food safety risks and ensuring that our manufacturing processes adhere to best practices.</p><p><br></p><h2>Responsibilities</h2><ul><li>Define, implement, and verify the effectiveness of the Pre-requisite Programs (PRP&#39;s) related to Hygiene, including hygienic zoning, risk management, pest control, cleaning validation and verification, pathogen monitoring, foreign body prevention, hygiene, and housekeeping.</li><li>Contribute to skills development of quality and operations personnel across the organization.</li><li>Define and update the specific quality and sanitation standard operating procedures, instructions, and tools required to operate in a facility.</li><li>Support operations and maintenance in ensuring GMP standards are adhered to.</li><li>Support the new product or process development through the risk assessment of new raw materials and processes.</li><li>Develop audit routines to ensure the effectiveness of the sanitation program.</li><li>Support activities to achieve compliance with organizational requirements and other applicable instructions and standards.</li><li>Own and deliver training related to hygiene, sanitation, and housekeeping as required.</li><li>Lead and support the development and implementation of Sanitation Standard Operation Procedures.</li><li>Recommend improvements to the master cleaning and master sanitation registers.</li><li>Support facility readiness for internal and external audits.</li><li>Perform troubleshooting and corrective action follow-up of non-conformities.</li><li>Comprehend and support plant protocols and programs, as well as facility systems, including informational/operational/management systems such as Acadia and QMS.</li><li>Develop and execute the environmental monitoring program.</li><li>Support sample collection and analysis at specified stages in the production process for evaluating compliance to specification.</li><li>Perform maintenance hygiene verification inspections.</li><li>Conduct CIP verification, pre-operational inspections, and collect pre-op cleaning verification swabs, reporting any concerns or deviations.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor’s degree in microbiology, biology, chemistry or a comparable program, or an equivalent combination of education and experience.</li><li>Experience successfully implementing sanitation, quality, or food safety programs by leading change or participating in project teams or improvement projects.</li><li>Demonstrated competence in hygiene and quality management.</li><li>Experience working in a microbiology or quality role in a food manufacturing environment.</li><li>Excellent verbal and written communication skills.</li><li>Proficiency in MS Office.</li><li>Strong writing, analytical, presentation, and critical thinking skills.</li><li>Detail-oriented and possesses strong decision-making ability.</li><li>Ability to keep accurate records.</li></ul>

Quality Hygenist

<h1><strong>Job Title: Quality Inspector - 1st Shift</strong></h1><p><br></p><h2>Job Description</h2><p>As a Quality Inspector, you will oversee incoming component inspections, in-line and in-process checks, and issue labels for special projects. You will conduct AQL inspections in response to customer complaints and manage rework processes. Your role involves handling over 1200 samples for production lots, ensuring quality checks of medical products throughout manufacturing and packaging. You will be responsible for checking for defects in bottles, totes, caps, and other packaging, pulling labels for batch records, documenting all inspections and batch record information, and ensuring compliance with GMPs, SOPs, FDA regulations, and quality processes.</p><p><br></p><h2>Responsibilities</h2><ul><li>Perform quality checks of medical products throughout the manufacturing and packaging process.</li><li>Inspect products for defects on bottles, totes, caps, and other packaging.</li><li>Pull labels on batch records for production personnel to use on external packaging.</li><li>Document all quality checks, inspections, and batch record information.</li><li>Ensure production personnel follow GMPs, SOPs, FDA regulations, and quality processes.</li></ul><h2>Essential Skills</h2><ul><li>Quality control experience.</li><li>High School Diploma.</li><li>Computer literacy in document writing (NCRs, NCMRs, Batch Record).</li><li>Legible writing and ability to work cross-functionally with production.</li><li>Verbal communication skills.</li><li>Experience with quality inspection, quality auditing, FDA inspections, GMP, FDA.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Understanding federal regulations is a plus.</li><li>GMP experience (can be trained).</li></ul><h2>Work Environment</h2><p>Hours are M-F 6am-2:30pm. The company manufactures OTC drugs, cosmetics, and medical devices, primarily producing lubricating jellies, shampoos, and saline syringes. The role is split equally between floor inspections/auditing and office-based documentation and project work. The company offers paid holidays and two weeks of prorated vacation annually. It is a growing company, expanding production lines, and encourages career growth from within.</p>

Quality Inspector

<h1 style="font-weight: 700;">Job Title: Quality Inspector/Technician</h1><br><h2>Job Description</h2><p>This position involves a balanced mix of on-the-floor activities and documentation tasks. Key responsibilities include supporting non-conforming material processes, corrective actions, customer feedback records, calibration, internal audits, and work instructions. The role also involves using a network analyzer for electrical testing and product analysis, along with providing training to others.</p><br><h2>Responsibilities</h2><ul><li>Support non-conforming material processes and corrective actions.</li><li>Maintain customer feedback records and calibration documentation.</li><li>Conduct internal audits and manage work instructions.</li><li>Use a network analyzer for electrical testing and product analysis.</li><li>Train and mentor other team members.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency with micrometer, caliper, ruler, and blueprint reading.</li><li>Experience in quality inspection and final inspection processes.</li><li>Ability to conduct electrical inspections and testing.</li><li>Experience in electrical crimping and wiring.</li><li>Knowledge of GD&amp;T, CMM, VSWR, VOP, RF standards.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Minimum 2 years of experience in quality inspecting.</li><li>Minimum 2 years of experience with electrical properties such as VSWR, VOP, RF, and Ethernet cable.</li><li>Minimum 1 year of experience with AS9100 standards.</li><li>Minimum 2 years of experience with pin gauges, micrometers, and calipers.</li><li>Ability to read and interpret drawings and blueprints.</li></ul><h2>Work Environment</h2><p>The work environment is a very clean, air-conditioned production floor with a small shop and family feel, consisting of around 40 employees. The facility has recently moved to a new location near Majestic Theatre and offers a great culture that is inviting and collaborative. The department includes five individuals, fostering a close-knit team dynamic.</p><br>

Quality Inspector/Technician

<h1 style="font-weight: 700;">Job Title: Quality Lab Technician</h1><br><h2>Job Description</h2><p>The Lab Technician performs each essential duty safely, satisfactorily, and in a timely manner. This role involves understanding and following batch tickets with high accuracy, performing complex testing processes on production batches, and maintaining a clean and organized work environment.</p><br><h2>Responsibilities</h2><ul><li>Understand and follow a batch ticket (recipe) with high degree of accuracy for weights and measurements.</li><li>Perform a wide variety of complex testing processes on production batches to measure product’s physical or chemical characteristics, including viscosity, weight per unit of measure, flow, gloss, and color characteristics.</li><li>Test materials from suppliers and production batches.</li><li>Perform standard testing procedures, including preparation of materials with attention to detail and high quality.</li><li>Follow daily work plan for Lab Work Request or project plan.</li><li>Accurately document work in lab notebooks, whether physical or electronic.</li><li>Recognize roadblocks or anomalies and resolve them or communicate concerns with a chemist in a timely manner.</li><li>Ensure raw materials are available and correctly labeled.</li><li>Correctly label and mail samples.</li><li>Maintain a clean and organized work environment.</li><li>Tint batches without assistance.</li><li>Calculate resin composites.</li><li>Maintain QC records using a web-based computer system.</li><li>Prepare records for submission.</li><li>Perform tests using lab equipment such as viscosity, pH, weight per gallon, and % solids.</li><li>Conduct draw downs and use ovens.</li><li>Maintain and perform calibrations on machines.</li></ul><h2>Essential Skills</h2><ul><li>Chemistry</li><li>Laboratory skills</li><li>Color matching</li><li>Quality control</li><li>Lab Technician experience</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Not color blind</li><li>Prior quality/wet lab experience or entry-level graduate with AS or BS in Science</li><li>Prior experience with color matching is a plus</li><li>Experience working with paint, pigments, and coatings</li><li>Industrial lab experience doing basic wet chemistry, including viscosity, pH, and % solids</li></ul><h2>Work Environment</h2><p>This role is based in an industrial lab environment within the plant. Personal protective equipment (PPE) such as lab coats and safety glasses will be provided. On the first day of training, steel-toed boots/shoes will be required, and reimbursement will be provided. The facility may have strong smells of chemicals and paint, so applicants should not be sensitive to those. The lab is large, with at least five people on each shift at all times.</p><br>

Quality Lab Technician

<h1>Quality Lab Technician</h1><p>As a Quality Lab Technician, you will play a crucial role in ensuring the safety and quality of dairy products. You will assist in the sanitation of the lab and equipment, conduct various tests and evaluations on products, and collaborate with the quality team to uphold high standards in food safety and quality control.</p><h2><br></h2><h2>Responsibilities</h2><ul><li>Sanitize the lab and equipment to maintain a clean working environment.</li><li>Prepare dilutions of milk and conduct chemical testing.</li><li>Verify the success of pasteurization by plating samples for E. coli and bacteria testing.</li><li>Incubate samples for further analysis.</li><li>Conduct testing of in-house water (city water) and perform sensory testing on milk, chocolate milk, and ice cream.</li><li>Package and label samples for external shipment.</li><li>Engage with Continuous Improvement (CI) initiatives and promote a culture of safety.</li><li>Perform sensory evaluations of product samples, both fresh and at shelf life.</li><li>Prepare samples, media, and solutions for chemical, physical, and microbiological analysis.</li><li>Conduct accurate microbiological analysis, including Coliform, Standard Plate Count, Yeast &amp; Mold.</li><li>Perform chemical and physical analyses such as Antibiotics, Freeze point analysis, Phosphatase, butterfat, Total solids, Brix, Titratable Acidity, and Vitamin analysis.</li><li>Operate, calibrate, maintain, and troubleshoot laboratory equipment like Foss FT120, Cryoscope, Horiba, Brix, and pH meters.</li><li>Perform quality checks and escalate any non-compliance issues to the quality leadership team.</li><li>Conduct pre-operational and sanitation checks, including visual inspections and ATP swabbing.</li><li>Check finished product labels, coding, and packaging.</li><li>Collect, transport, store, test, and dispose of samples properly.</li><li>Maintain the Environmental Monitoring and Allergen Programs, including air and water quality assessments.</li><li>Coordinate sampling and shipments with third-party laboratories and handle customer requests.</li><li>Maintain an inventory of laboratory supplies, ensuring proper stock levels and rotation.</li><li>Organize and maintain production and quality control records in compliance with regulations.</li><li>Enter data and create reports promptly and accurately.</li><li>Ensure records are accurate and legible, adhering to Good Documentation Practices (GDPs).</li><li>Maintain laboratory cleanliness and follow Good Laboratory Practices (GLPs).</li><li>Follow all Good Manufacturing Practices (GMPs) and established quality and safety policies.</li><li>Participate in laboratory proficiency programs and identify process improvements.</li><li>Orient and instruct others in job duties when required.</li><li>Assist Quality Assurance Supervisor and Manager in special projects and other assigned duties.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor&#39;s degree in Microbiology, Food Science, Agriculture, or a related science field preferred.</li><li>Knowledge of Good Laboratory Practices (GLPs) and Good Documentation Practices (GDPs).</li><li>Understanding of quality assurance and HACCP systems.</li><li>Ability to work well in a team and independently.</li><li>Strong time management and organizational skills.</li><li>Proficient in Microsoft Outlook, Word, Excel, and PowerPoint.</li><li>Excellent interpersonal, written, and verbal communication skills.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in the microbiology field, either academic or industry-related.</li><li>Experience demonstrating teamwork, time management, and process improvement abilities.</li><li>Students from UC Davis are a plus.</li><li>Self-starter with the ability to complete tasks without close supervision.</li><li>Exposure to the dairy industry is beneficial.</li></ul><h2>Work Environment</h2><p>This position is a night shift, working from 6:00 pm - 2:30 am. The role involves working 70% in the lab and 30% in the plant/data/paperwork. The quality team consists of three technicians, an SQF coordinator, and a QA manager. You will primarily work independently in the lab, with some crossover with other technicians at the <span style="color: rgb(8, 7, 7); background-color: none;">beginning</span> and end of your shift. Support is available from the QA manager or SQF coordinator if needed. Occasionally, there may be collaboration with the sanitation supervisor.</p>

<h1 style="font-weight: 700;">Job Title: Quality Lab Technician</h1><br><h2>Job Description</h2><p>We are seeking a detail-oriented and motivated Chemical Lab &amp; Quality Technician. This role involves hands-on work in process control, chemical analysis, quality assurance, and environmental compliance. The ideal candidate will thrive in a collaborative environment and contribute to maintaining high standards in metal treatment and regulatory reporting.</p><br><h2>Responsibilities</h2><ul><li>Conduct daily solution analyses and calculate necessary chemical additions.</li><li>Monitor and report out-of-range readings and supply needs.</li><li>Perform scheduled water and waste treatment analyses.</li><li>Troubleshoot waste treatment issues and coordinate with maintenance.</li><li>Schedule and document bath changes and waste pickups.</li><li>Perform reliability tests such as salt spray and adhesion.</li><li>Conduct in-process and final inspections; document results.</li><li>Review specifications with Quality and Engineering teams.</li><li>Manage customer-facing corrective actions and quality reports.</li><li>Support internal and external audits, including NADCAP compliance.</li><li>Maintain calibration logs and issue Certificates of Compliance.</li><li>Develop and deliver quality training materials and documentation.</li><li>Participate in root cause analysis and corrective action planning.</li><li>Attend production meetings to prioritize quality issues.</li><li>Contribute to process improvement initiatives and cost-of-quality reporting.</li></ul><h2>Essential Skills</h2><ul><li>Chemistry</li><li>Laboratory work</li><li>Quality control</li><li>Environmental compliance</li><li>Water analysis</li><li>Quality testing</li><li>Chemical lab experience</li><li>Quality assurance</li><li>Environmental testing</li><li>Plating</li><li>Coating</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in chemical and environmental testing</li><li>Ability to conduct daily solution analyses and calculate chemical additions</li><li>Experience in performing reliability tests such as salt spray and adhesion</li><li>Capability to manage customer-facing corrective actions and quality reports</li><li>Familiarity with NADCAP compliance</li><li>Experience in developing and delivering quality training materials</li></ul><h2>Work Environment</h2><p>This position is set in a very industrial environment with a small lab consisting of only three people at a time. The production floor can be loud and busy. Work hours are Monday through Friday from 2:30pm to 11pm, with an expectation of 40-45 hours per week. The company environment is technically rigorous, fast-moving, and compliance-heavy, featuring a mix of tight-knit leadership and operational intensity. While some employees thrive in the dynamic pace and team culture, others have noted challenges around stress, advancement, and internal dynamics.</p><br>

<h1 style="text-align: center;"><strong><u>Quality Lab Technician</u></strong></h1><p style="text-align: center;"><br></p><p style="text-align: center;">INTERESTED CANDIDATES MAY SEND UPDATED RESUMES TO: JGASSER @ ACTALENTSERVICES.COM </p><p style="text-align: center;">OR TEXT JENNA TO SETUP A PHONE INTERVIEW: 419. 980. 5823</p><p><br></p><p><strong><u>Job Description</u></strong></p><p>The Lab Technician performs each essential duty safely, satisfactorily, and in a timely manner. This role involves understanding and following batch tickets with high accuracy, performing complex testing processes on production batches, and maintaining a clean and organized work environment.</p><p><br></p><p><strong><u>Responsibilities</u></strong></p><ul><li>Understand and follow a batch ticket (recipe) with high degree of accuracy for weights and measurements.</li><li>Perform a wide variety of complex testing processes on production batches to measure product’s physical or chemical characteristics, including viscosity, weight per unit of measure, flow, gloss, and color characteristics.</li><li>Test materials from suppliers and production batches.</li><li>Perform standard testing procedures, including preparation of materials with attention to detail and high quality.</li><li>Follow daily work plan for Lab Work Request or project plan.</li><li>Accurately document work in lab notebooks, whether physical or electronic.</li><li>Recognize roadblocks or anomalies and resolve them or communicate concerns with a chemist in a timely manner.</li><li>Ensure raw materials are available and correctly labeled.</li><li>Correctly label and mail samples.</li><li>Maintain a clean and organized work environment.</li><li>Tint batches without assistance.</li><li>Calculate resin composites.</li><li>Maintain QC records using a web-based computer system.</li><li>Prepare records for submission.</li><li>Perform tests using lab equipment such as viscosity, pH, weight per gallon, and % solids.</li><li>Conduct draw downs and use ovens.</li><li>Maintain and perform calibrations on machines.</li></ul><p><strong><u>Essential Skills</u></strong></p><ul><li>Chemistry</li><li>Laboratory skills</li><li>Color matching</li><li>Quality control</li><li>Lab Technician experience</li></ul><p><strong><u>Additional Skills &amp; Qualifications</u></strong></p><ul><li>Not color blind</li><li>Prior quality/wet lab experience or entry-level graduate with AS or BS in Science</li><li>Prior experience with color matching is a plus</li><li>Experience working with paint, pigments, and coatings</li><li>Industrial lab experience doing basic wet chemistry, including viscosity, pH, and % solids</li></ul><p><strong><u>Work Environment</u></strong></p><p>This role is based in an industrial lab environment within the plant. Personal protective equipment (PPE) such as lab coats and safety glasses will be provided. On the first day of training, steel-toed boots/shoes will be required, and reimbursement will be provided. The facility may have strong smells of chemicals and paint, so applicants should not be sensitive to those. The lab is large, with at least five people on each shift at all times.</p>

<h1 style="text-align: center;"><strong>Quality Lab Technician</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a detail-oriented and motivated Chemical Lab &amp; Quality Technician. This role involves hands-on work in process control, chemical analysis, quality assurance, and environmental compliance. The ideal candidate will thrive in a collaborative environment and contribute to maintaining high standards in metal treatment and regulatory reporting.</p><p><br></p><h2>Responsibilities</h2><ul><li>Conduct daily solution analyses and calculate necessary chemical additions.</li><li>Monitor and report out-of-range readings and supply needs.</li><li>Perform scheduled water and waste treatment analyses.</li><li>Troubleshoot waste treatment issues and coordinate with maintenance.</li><li>Schedule and document bath changes and waste pickups.</li><li>Perform reliability tests such as salt spray and adhesion.</li><li>Conduct in-process and final inspections; document results.</li><li>Review specifications with Quality and Engineering teams.</li><li>Manage customer-facing corrective actions and quality reports.</li><li>Support internal and external audits, including NADCAP compliance.</li><li>Maintain calibration logs and issue Certificates of Compliance.</li><li>Develop and deliver quality training materials and documentation.</li><li>Participate in root cause analysis and corrective action planning.</li><li>Attend production meetings to prioritize quality issues.</li><li>Contribute to process improvement initiatives and cost-of-quality reporting.</li></ul><h2>Essential Skills</h2><ul><li>Chemistry</li><li>Laboratory work</li><li>Quality control</li><li>Environmental compliance</li><li>Water analysis</li><li>Quality testing</li><li>Chemical lab experience</li><li>Quality assurance</li><li>Environmental testing</li><li>Plating</li><li>Coating</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in chemical and environmental testing</li><li>Ability to conduct daily solution analyses and calculate chemical additions</li><li>Experience in performing reliability tests such as salt spray and adhesion</li><li>Capability to manage customer-facing corrective actions and quality reports</li><li>Familiarity with NADCAP compliance</li><li>Experience in developing and delivering quality training materials</li></ul><h2>Work Environment</h2><p>This position is set in a very industrial environment with a small lab consisting of only three people at a time. The production floor can be loud and busy. Work hours are Monday through Friday from 2:30pm to 11pm, with an expectation of 40-45 hours per week. The company environment is technically rigorous, fast-moving, and compliance-heavy, featuring a mix of tight-knit leadership and operational intensity. While some employees thrive in the dynamic pace and team culture, others have noted challenges around stress, advancement, and internal dynamics.</p>

<h1><strong>Apply today to join a company that strives to nourish the community with quality dairy products! </strong></h1><p>As a Quality Lab Technician, you will play a crucial role in ensuring the safety and quality of dairy products. You will assist in the sanitation of the lab and equipment, conduct various tests and evaluations on products, and collaborate with the quality team to uphold high standards in food safety and quality control.</p><h2>Responsibilities</h2><ul><li>Sanitize the lab and equipment to maintain a clean working environment.</li><li>Prepare dilutions of milk and conduct chemical testing.</li><li>Verify the success of pasteurization by plating samples for E. coli and bacteria testing.</li><li>Incubate samples for further analysis.</li><li>Conduct testing of in-house water (city water) and perform sensory testing on milk, chocolate milk, and ice cream.</li><li>Package and label samples for external shipment.</li><li>Engage with Continuous Improvement (CI) initiatives and promote a culture of safety.</li><li>Perform sensory evaluations of product samples, both fresh and at shelf life.</li><li>Prepare samples, media, and solutions for chemical, physical, and microbiological analysis.</li><li>Conduct accurate microbiological analysis, including Coliform, Standard Plate Count, Yeast &amp; Mold.</li><li>Perform chemical and physical analyses such as Antibiotics, Freeze point analysis, Phosphatase, butterfat, Total solids, Brix, Titratable Acidity, and Vitamin analysis.</li><li>Operate, calibrate, maintain, and troubleshoot laboratory equipment like Foss FT120, Cryoscope, Horiba, Brix, and pH meters.</li><li>Perform quality checks and escalate any non-compliance issues to the quality leadership team.</li><li>Conduct pre-operational and sanitation checks, including visual inspections and ATP swabbing.</li><li>Check finished product labels, coding, and packaging.</li><li>Collect, transport, store, test, and dispose of samples properly.</li><li>Maintain the Environmental Monitoring and Allergen Programs, including air and water quality assessments.</li><li>Coordinate sampling and shipments with third-party laboratories and handle customer requests.</li><li>Maintain an inventory of laboratory supplies, ensuring proper stock levels and rotation.</li><li>Organize and maintain production and quality control records in compliance with regulations.</li><li>Enter data and create reports promptly and accurately.</li><li>Ensure records are accurate and legible, adhering to Good Documentation Practices (GDPs).</li><li>Maintain laboratory cleanliness and follow Good Laboratory Practices (GLPs).</li><li>Follow all Good Manufacturing Practices (GMPs) and established quality and safety policies.</li><li>Participate in laboratory proficiency programs and identify process improvements.</li><li>Orient and instruct others in job duties when required.</li><li>Assist Quality Assurance Supervisor and Manager in special projects and other assigned duties.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor&#39;s degree in Microbiology, Food Science, Agriculture, or a related science field preferred.</li><li>Knowledge of Good Laboratory Practices (GLPs) and Good Documentation Practices (GDPs).</li><li>Understanding of quality assurance and HACCP systems.</li><li>Ability to work well in a team and independently.</li><li>Strong time management and organizational skills.</li><li>Proficient in Microsoft Outlook, Word, Excel, and PowerPoint.</li><li>Excellent interpersonal, written, and verbal communication skills.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in the microbiology field, either academic or industry-related.</li><li>Experience demonstrating teamwork, time management, and process improvement abilities.</li><li>Students from UC Davis are a plus.</li><li>Self-starter with the ability to complete tasks without close supervision.</li><li>Exposure to the dairy industry is beneficial.</li></ul><h2>Work Environment</h2><p>This position is a night shift, working from 6:00 pm - 2:30 am. The role involves working 70% in the lab and 30% in the plant/data/paperwork. The quality team consists of three technicians, an SQF coordinator, and a QA manager. You will primarily work independently in the lab, with some crossover with other technicians at the <span style="color: rgb(8, 7, 7); background-color: none;">beginning</span> and end of your shift. Support is available from the QA manager or SQF coordinator if needed. Occasionally, there may be collaboration with the sanitation supervisor.</p>

Quality Lab Technician (Chemistry)

<h1 style="text-align: center;"><strong>Job Title: Quality Laboratory Technician</strong></h1><p style="text-align: center;"><em>**INTERVIEWS AVAILABLE THIS WEEK**</em></p><p style="text-align: center;"><strong>﻿Interested in this role? </strong>Reach out directly to <strong>mrichey<em>@actalentservices .com or CALL 317 567 </em>6591 </strong>with an updated resume to apply (HIRING NOW)</p><p style="text-align: center;">**Located In Lafayette*</p><h2>Job Description</h2><p>The Quality Laboratory Technician plays a crucial role in ensuring the highest standards of quality assurance and control within the laboratory. This position involves working primarily with sweeteners, corn syrups, and sugar products, which are processed into corn sweeteners such as high fructose corn syrup, sugar, and starches for human and animal feed. The laboratory is divided into chemistry and microbiology sections, where technicians perform extractions and work on liquid products.</p><p><br></p><h2>Responsibilities</h2><ul><li>Prepare and analyze various final product and in-process samples using analytical instruments and wet chemistry techniques.</li><li>Facilitate plant process flow by providing timely and accurate analysis results.</li><li>Post analysis results into data systems and communicate findings to plant personnel.</li><li>Recognize abnormal findings and collaborate with process teams to resolve issues.</li><li>Conduct final QA/QC of outbound shipments and document results.</li><li>Follow established analysis methodologies and perform basic laboratory equipment maintenance.</li><li>Support other departments with analytical and project-based efforts on an ad hoc basis.</li><li>Ensure adherence to all company policies and procedures and demonstrate core values.</li><li>Support a 24/7 process by working a rotating shift, including nights, weekends, and holidays.</li><li>Advance through skill block system, achieving four &#39;operate&#39; skill blocks and a &#39;basic&#39; skill block.</li><li>Perform other duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>A 4-year degree in Chemistry, Biology, or another relevant scientific discipline.</li><li>Ability to prepare and analyze in-process and finished goods using various laboratory methodologies and equipment.</li><li>Experience and understanding of HPLC, GC, AA, NIR, pH, and other laboratory techniques.</li><li>Willingness to support a 24/7 process and work rotating shifts, including nights, weekends, and holidays.</li><li>Ability to multitask, prioritize, and maintain attention to detail.</li><li>Excellent written and verbal communication skills.</li><li>Self-starting and detail-oriented with good troubleshooting skills.</li><li>Strong computer skills, including proficiency in Microsoft Office Applications.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Knowledge and experience with SAP is a plus.</li></ul><h2>Work Environment</h2><p>Candidates will work 12-hour shifts, typically 3 days on and 3 days off, rotating between day and night shifts (e.g., 5 AM to 5 PM for 3 days, off for 3 days, then 5 PM to 5 AM for 3 days, off for 3 days). The role requires standing for extended periods, and the dress code includes jeans and a t-shirt.</p><p><br></p><p><strong>INTERESTED IN THIS ROLE? SEE BELOW TO APPLY NOW FOR IMMEDIATE CONSIDERTATION:</strong></p><p>I am scheduling interviews for this position <strong>ASAP </strong>and conducting phone interviews as early as today. All candidates will be considered immediately within 24 hours of applying directly to <strong>Max Richey</strong></p><p><strong>HOW TO APPLY DIRECTLY: </strong>Email your updated resume, brief intro about your interest, preferred method of communication for you (i.e., call, email, text) to <strong><u>mrichey@actalentservices. com or CALL 317 567 6591</u></strong></p>

Quality Laboratory Technician

<p style="text-align: center;"><strong><em>HIRING NOW</em>: </strong>﻿ <strong>Food Safety &amp; Quality Lead</strong></p><p style="text-align: center;"><em>**INTERVIEWS AVAILABLE THIS WEEK**</em></p><p style="text-align: center;"><strong>﻿Interested in this role? </strong>Reach out directly to <strong>mrichey<em>@actalentservices .com or CALL 317 567 </em>6591 </strong>with an updated resume to apply (HIRING NOW)</p><p style="text-align: center;">*Located In Wolcott*</p><p><br></p><h2>Job Description</h2><p>The Food Safety &amp; Quality Supervisor is entrusted with overseeing daily operations related to food safety and quality assurance in a food manufacturing environment. This role is pivotal in ensuring compliance with regulatory standards and internal protocols, supporting continuous improvement initiatives, and fostering a robust culture of food safety across the facility.</p><p><br></p><h2>Responsibilities</h2><ul><li>Manage and maintain food safety and quality programs, including HACCP, GMPs, SSOPs, and allergen control.</li><li>Conduct facility inspections, internal audits, and risk assessments to ensure compliance with USDA, FDA, and other applicable regulations.</li><li>Supervise and train quality assurance staff on food safety procedures and documentation.</li><li>Investigate and resolve quality issues, customer complaints, and non-conformances.</li><li>Maintain accurate records of inspections, testing, and corrective actions.</li><li>Collaborate with cross-functional teams to support product launches and process improvements.</li><li>Prepare for and participate in third-party audits and regulatory inspections.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor’s degree in Food Science, Microbiology, or a related field.</li><li>Minimum of 3 years of experience in food manufacturing, preferably in a USDA-regulated facility.</li><li>Certifications such as PCQI, HACCP, or SQF Practitioner are preferred.</li><li>Strong understanding of food safety regulations and quality systems.</li><li>Excellent communication, leadership, and analytical skills.</li><li>Proficiency in Microsoft Office and quality management software.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in food &amp; beverage manufacturing, specifically within quality.</li><li>Certifications like HACCP Certification, PCQI Certification, SQF Practitioner, or other GSQI.</li><li>Experience with food safety standards.</li><li>Knowledge of chemistry and laboratory procedures.</li></ul><h2>Work Environment</h2><p>The position is within a start-up manufacturing company producing egg replacement wraps. The work culture is collaborative, with close relationships across departments, especially between R&amp;D and quality teams. The supervisor will oversee five lab technicians across multiple shifts. The typical work schedule is Monday to Friday, from 7 AM to 4 PM, with occasional on-call rotations. The environment supports growth, with opportunities to gain certifications internally, such as PCQI.</p><p><br></p><p><strong>INTERESTED IN THIS ROLE? SEE BELOW TO APPLY NOW FOR IMMEDIATE CONSIDERTATION:</strong></p><ul><li>I am scheduling interviews for this position <strong>ASAP </strong>and conducting phone interviews as early as today. All candidates will be considered immediately within 24 hours of applying directly to <strong>Max Richey</strong></li><li><strong>HOW TO APPLY DIRECTLY: </strong>Email your updated resume, brief intro about your interest, preferred method of communication for you (i.e., call, email, text) to <strong><u>mrichey@actalentservices. com or CALL 317 567 6591</u></strong></li></ul>

Quality Lead

<h1 style="font-weight: 700;">Job Title: Quality Lead</h1><br><h2>Job Description</h2><p>The Quality Lead is responsible for ensuring product integrity throughout the production process. This role is ideal for candidates with strong attention to detail, hands-on experience with precision measurement tools, and the ability to communicate effectively with internal teams and external partners.</p><br><h2>Responsibilities</h2><ul><li>Conduct incoming, in-process, and final inspections using tools such as calipers, micrometers, microscopes, and vision systems for micro parts.</li><li>Perform lab-based measurements including pH testing, viscosity, and moisture analysis using specialized equipment.</li><li>Execute pull force and burst testing to verify product durability and compliance.</li><li>Schedule and coordinate specialized testing with external laboratories when needed.</li><li>Ensure product quality through detailed visual assessments before release.</li></ul><h2>Essential Skills</h2><ul><li>2-5 years of experience with hands-on inspection.</li><li>Strong communication and reporting skills.</li><li>Experience within a Medical Device/Pharmaceutical setting is preferred but not required.</li><li>Proficiency in inspection, testing, and metrology.</li><li>Hands-on experience with precision measurement tools such as calipers, micrometers, and microscopes.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in quality inspection and visual assessment.</li><li>Knowledge of testing methods including pH testing, moisture testing, pull force testing, and burst testing.</li></ul><h2>Work Environment</h2><p>The position is 100% onsite with a start time of 6am. The team consists of 80 employees across two locations, with 5 dedicated to quality (including 3 technicians). The primary worksite is the production facility located at 510 S Vermont Ave, Glendora, with some time spent at the headquarters at 2035 E Financial Way, Glendora. The company offers a supportive team environment, early shift schedules, and a strong focus on work-life balance.</p><br>

<p><strong>Description</strong></p><p>We are seeking a meticulous and detail-oriented Quality Control Technician to join our clients team. The successful candidate will be responsible for performing final inspections on cosmetic and personal care products to ensure they meet our high-quality standards and comply with Good Manufacturing Practices (GMP). This role is critical in maintaining the integrity and safety of our products before they reach our customers.</p><p><br></p><p><strong>Key Responsibilities:</strong></p><p><br></p><ul><li>Conduct final inspections of finished products to ensure they meet quality specifications and GMP standards.</li><li>Verify that all products are correctly labeled and packaged according to company and regulatory requirements.</li><li>Inspect products for defects, inconsistencies, and deviations from established quality standards.</li><li>Document inspection results and maintain accurate records of findings.</li><li>Collaborate with production and quality teams to address and resolve any quality issues identified during inspections.</li><li>Assist in the development and implementation of quality control procedures and protocols.</li><li>Participate in internal audits and support external audits as needed.</li><li>Ensure compliance with all safety, health, and environmental regulations.</li><li>Provide feedback and recommendations for continuous improvement in quality assurance processes.</li></ul><p><br></p><p><strong>Skills</strong></p><p>Visual, quality, batch record, GMP, SOP, COA, Good Manufacturing Practices, Inspection, Quality Control, Quality Assurance, Quality check, Line inspection, label, caps, production, product release, verify</p><p><br></p><p><strong>Top Skills Details</strong></p><p>Visual inspection, quality control, batch record</p><p><br></p><p><strong>Additional Skills &amp; Qualifications</strong></p><p>•	A minimum of 1 year of experience in quality.  Experience in the cosmetic/pharmaceutical/ Med Device industry is preferred.</p><p>•	Working knowledge of Microsoft Word, Excel and Outlook.</p><p>•	Quality Control/Assurance knowledge in a cGMP environment is required.</p><p>•	Ability to prioritize, multitask and manage time well.</p><p>•	Excellent written and verbal communication skills.</p><p>•	Attention to detail.</p><p>•	Ability to follow written and verbal directions.</p><p>•	Motivated and works well with others.</p><p><br></p>

Quality Line Inspector

<h1><strong>Quality Manager</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a dedicated Quality Manager to implement, execute, and promote food safety practices within our products. The successful candidate will uphold Good Manufacturing Practices (GMPs), adhere to Standard Operating Procedures (SOPs), and maintain compliance with regulatory standards such as FDA cGMP, EXCiPACT, and BRC. You will lead quality program planning to ensure our product and quality systems meet customer specifications and regulatory requirements.</p><p><br></p><h2>Responsibilities</h2><ul><li>Direct and oversee the quality program to ensure compliance with customer specifications and regulatory standards.</li><li>Manage lab operations, including planning and scheduling laboratory coverage and approving timecards.</li><li>Provide developmental and annual training to the quality team to enhance their skills in quality techniques and troubleshooting.</li><li>Ensure a safe working environment for all quality employees.</li><li>Communicate facility quality performance through various formats to management, operations, and warehouse staff.</li><li>Coordinate and conduct development, maintenance, and validation of test methods.</li><li>Assist in developing, updating, and maintaining product specifications.</li><li>Support engineering and technology teams in new product developments and process improvements.</li><li>Maintain Lab QMS System (LX-400) databases.</li><li>Research, propose, purchase, and set up new instrumentation within budget and timeframe.</li><li>Propose, write, and review quality control Standard Operating Procedures.</li><li>Perform statistical analysis of test results for internal trending.</li><li>Provide backup support for QA and QC Coordinators and Chemical Analysts as needed.</li><li>Collaborate with various departments to lead projects focusing on cost savings, quality improvements, and new product development utilizing Lean Six Sigma methodologies.</li><li>Work with plant leadership to ensure project outcomes meet quality standards.</li><li>Perform additional duties as defined by the manager.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor’s Degree in Food Science, Engineering, Life Sciences, or a similar field.</li><li>Five years of experience in quality and/or regulatory leadership in a food manufacturing setting.</li><li>Experience with food safety/quality programs, including HACCP, GMPs, SPC, and exposure to Continuous Improvement programs like Six Sigma and TQM.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Strong leadership and communication skills.</li><li>Ability to manage and develop a team effectively.</li><li>Proficiency in statistical analysis and quality management systems.</li></ul><h2>Work Environment</h2><p>This role is based in an industrial food manufacturing facility. You will lead a team comprising a Quality Supervisor, Quality Control Technicians, a Document Control Specialist, and a QA Coordinator. The position requires overseeing three process areas for sample collection and maintaining alignment with company directives. The position is open due to the current quality manager&#39;s notice, and we are seeking to fill it as soon as possible. Shift flexibility is available. The team is responsible for critical process characteristics, standards, audits, and complaint resolutions, ensuring that team goals align with the company&#39;s objectives.</p>

Quality Manager

<h1><strong>Job Title: Quality Manager – Automotive Seating (EV)</strong></h1><p><br></p><h2>Job Description</h2><p>A global automotive supplier seeks a Quality Manager to lead and develop a team of quality professionals at one of its high-impact EV seating manufacturing sites in either Champaign, IL. This is a critical leadership role with direct visibility to site leadership and OEM customers.</p><p><br></p><h2>Responsibilities</h2><ul><li>Lead and develop a team of up to 10 quality professionals, including team leads, specialists, and assistant managers.</li><li>Oversee quality documentation, audits, and compliance with customer and industry standards.</li><li>Collaborate cross-functionally with production and engineering teams to drive continuous improvement.</li><li>Serve as the primary quality contact for OEM customers.</li><li>Report directly to the site CEO.</li></ul><h2>Essential Skills</h2><ul><li>5+ years of experience in a quality leadership role within automotive manufacturing.</li><li>Proficiency in GD&amp;T, color measurement systems, and quality documentation.</li><li>Must pass a color vision assessment.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor’s degree required; Master’s preferred.</li><li>Experience in seating systems and/or EV manufacturing strongly preferred.</li><li>Experience with seating manufacturing and Tier 1 Automotive experience is a plus.</li></ul><h2>Work Environment</h2><p>The role is 100% onsite, first shift, from Monday to Friday in a fast-paced, hands-on manufacturing setting. The company values safety, structure, and continuous improvement, with a strong emphasis on safety, health, and environmental responsibility. They have implemented international standards such as ISO and conduct monthly on-site safety inspections. The culture values visibility, accountability, and direct leadership.</p>

<h1><strong>Job Title: Quality Manager</strong></h1><p><br></p><h2>Job Description</h2><p>The Quality Manager plays a crucial role in ensuring the safety and quality of products manufactured at the facility. This position involves the development, implementation, and maintenance of food safety and quality management systems that comply with regulatory, customer, and GFSI standards.</p><p><br></p><h2>Responsibilities</h2><ul><li>Ensure the safety and quality of products manufactured at the facility.</li><li>Develop, implement, and maintain food safety and quality management systems that are regulatory, customer, and GFSI compliant.</li><li>Review, revise, implement, and monitor Food Safety Plans, HACCP, SSOP, and GMP.</li><li>Serve as SQF practitioner; oversee SQF program implementation and certification audits to successful outcomes.</li><li>Oversee sanitation and pest control, managing vendor relationships and corrective actions.</li><li>Understand manufacturing operations to identify critical processes and controls.</li><li>Track, report, and review food safety and quality KPIs.</li><li>Lead quality improvement initiatives.</li><li>Conduct root cause analysis and implement corrective/preventive actions.</li><li>Manage consumer complaints and resolve quality issues.</li><li>Collaborate on product/process changes to ensure safety and quality.</li><li>Promote continuous improvement in FSQA through program updates, technology adoption, process enhancements, and departmental efficiencies.</li><li>Lead food safety and quality training and foster a strong food safety culture.</li><li>Lead and develop the site FSQA team.</li><li>Govern and manage the Master Sanitation program, ensuring adherence and effectiveness.</li></ul><h2>Essential Skills</h2><ul><li>Quality assurance expertise.</li><li>Proficiency in GMP, HACCP, and FDA regulations.</li><li>Experience in batch record review and document control.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor&#39;s Degree required.</li><li>3+ years of experience within food safety and quality.</li><li>2+ years of leadership experience.</li></ul><h2>Schedule</h2><p>The position operates on a Monday-Friday 1st shift schedule. </p>

<h1 style="font-weight: 700;">Job Title: Quality Manager</h1><br><h2>Job Description</h2><p>Responsible for overseeing the Quality Department and direct reports, ensuring the overall quality of our products.</p><br><h2>Responsibilities</h2><ul><li>Train employees on quality requirements.</li><li>Conduct internal auditing and day-to-day inspections.</li><li>Oversee product testing and manage employee training and audits.</li><li>Address customer issues and conduct customer audits.</li><li>Perform supplier audits and ensure compliance.</li><li>Conduct IPC training and certification.</li><li>Manage PPAP and FAI reporting.</li><li>Handle NCM/RMA disposition.</li><li>Develop tests on automated harness testers.</li><li>Issue non-conformances and maintain a log for customer reports.</li></ul><h2>Essential Skills</h2><ul><li>Minimum 3 years of quality experience as a lead.</li><li>Minimum 3 years of experience in a relevant environment.</li><li>Minimum 3 years of experience working with and documenting PPAPs.</li><li>Minimum 1 year of experience working with cables and wiring.</li><li>Ability to interpret drawings within AutoCAD and blueprints.</li><li>Minimum 1 year of experience leading a team.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience with quality inspection, harness, and cable harness.</li></ul><h2>Work Environment</h2><p>This role is within a small, growing company involved in major markets including medical, automotive, agriculture, and hydraulic power. The company employs approximately 35-40 individuals. The work schedule is Monday to Friday with occasional Saturdays. Summer hours (Memorial Day to Labor Day) are 6am-3pm Monday through Thursday and 6am-Noon on Friday. Non-summer hours are 6am-2:30pm Monday through Friday. The company is ISO 9001:2015 certified and practices Lean Manufacturing.</p><br>

<h1 style="font-weight: 700;">Job Title: Quality Manager</h1><br><h2>Job Description</h2><p>The Quality Manager is responsible for ensuring the uncompromised quality of all products, processes, services, and systems across internal and external production, global supply chains, and distribution channels. This role oversees the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with ISO9001:2015, CE Module D, and other applicable international PPE standards. This position is both strategic and hands-on, requiring strong leadership in quality systems, manufacturing quality, supplier quality, product compliance, corrective actions, and certification management. Working collaboratively across departments, the Quality Manager leads efforts in continuous improvement, process auditing, performance tracking, corrective action resolution, and compliance assurance. The role fosters a culture of quality, learning, and teamwork aligned with customer needs and long-term business sustainability.</p><br><h2>Responsibilities</h2><ul><li>Ensure uncompromised quality of all products, processes, services, and systems.</li><li>Oversee implementation, maintenance, and continuous improvement of the Quality Management System (QMS).</li><li>Ensure compliance with ISO9001:2015, CE Module D, and other applicable international PPE standards.</li><li>Lead quality systems, manufacturing quality, supplier quality, product compliance, corrective actions, and certification management.</li><li>Collaborate across departments to promote continuous improvement, process auditing, performance tracking, corrective action resolution, and compliance assurance.</li><li>Foster a culture of quality, learning, and teamwork.</li></ul><h2>Essential Skills</h2><ul><li>Strong experience with ISO 9000 QMS and auditing.</li><li>Mastery of quality tools and processes.</li><li>Advanced statistical analysis skills.</li><li>Proficiency in Excel and analytical software.</li><li>Excellent communication and problem-solving skills.</li><li>Skilled in quality measurement, testing, and systems application.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience with Lean, Continuous Improvement, SPC; Six Sigma certification preferred.</li><li>Knowledge of mechanical design, GD&amp;T, and metrology is a plus.</li><li>ASQ certifications (CQE, CQM, CQA) preferred.</li><li>Familiarity with rescue equipment is a bonus.</li><li>Bilingual in English and Spanish is a plus.</li><li>Must maintain punctuality and adhere to company policies.</li></ul><h2>Work Environment</h2><p>The work environment is dynamic and collaborative, emphasizing teamwork and continuous learning. You will work with advanced quality tools and systems, ensuring adherence to industry standards. The position requires adherence to company policies and punctuality, fostering a professional and disciplined work culture.</p><br>

<h1><strong>Job Title: Quality Manager</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking an experienced Quality Manager to lead and maintain our Quality Management System (QMS) in compliance with FDA and other regulatory requirements. This role involves managing audits, overseeing quality processes, and collaborating with cross-functional teams to ensure product excellence.</p><p><br></p><h2>Responsibilities</h2><ul><li>Lead and maintain the company’s QMS in compliance with FDA and other regulatory requirements.</li><li>Manage internal and external audits, including FDA inspections and ISO certification audits.</li><li>Oversee CAPA, nonconformance, and complaint handling processes.</li><li>Collaborate with cross-functional teams (R&amp;D, Manufacturing, Regulatory) to ensure quality is built into every stage of the product lifecycle.</li><li>Develop and monitor quality metrics and KPIs; report findings to leadership.</li><li>Lead training programs on quality standards, procedures, and best practices.</li><li>Manage document control, change control, and risk management processes.</li><li>Supervise quality assurance and quality control staff.</li><li>Other duties and special projects as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Quality engineering</li><li>Quality assurance</li><li>Root cause analysis</li><li>Medical device industry experience</li><li>CAPA</li><li>Quality management</li><li>AS9100</li><li>Quality management system</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).</li><li>5+ years of experience in quality management within the medical device industry.</li><li>Strong knowledge of FDA QSR and risk management (ISO standards).</li><li>Experience with CAPA, root cause analysis, and audit readiness.</li><li>Excellent leadership, communication, and problem-solving skills.</li><li>ASQ certifications (e.g., CQE, CQA) are a plus.</li></ul><h2>Work Environment</h2><p>This position involves working closely with cross-functional teams and requires strong collaboration skills. The work environment prioritizes compliance with regulatory standards and continuous improvement. Typical office attire is expected.</p>

<h1><strong>Job Title: Quality Manager – Automotive Seating (EV)</strong></h1><p><br></p><h2>Job Description</h2><p>A global automotive supplier seeks a Quality Manager to lead and develop a team of quality professionals at one of its high-impact EV seating manufacturing sites in either Champaign, IL or Mesa, AZ. This is a critical leadership role with direct visibility to site leadership and OEM customers.</p><p><br></p><h2>Responsibilities</h2><ul><li>Lead and develop a team of up to 10 quality professionals, including team leads, specialists, and assistant managers.</li><li>Oversee quality documentation, audits, and compliance with customer and industry standards.</li><li>Collaborate cross-functionally with production and engineering teams to drive continuous improvement.</li><li>Serve as the primary quality contact for OEM customers.</li><li>Report directly to the site CEO.</li></ul><h2>Essential Skills</h2><ul><li>5+ years of experience in a quality leadership role within automotive manufacturing.</li><li>Proficiency in GD&amp;T, color measurement systems, and quality documentation.</li><li>Must pass a color vision assessment.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor’s degree required; Master’s preferred.</li><li>Experience in seating systems and/or EV manufacturing strongly preferred.</li><li>Experience with seating manufacturing and Tier 1 Automotive experience is a plus.</li></ul><h2>Work Environment</h2><p>The role is 100% onsite, first shift, from Monday to Friday in a fast-paced, hands-on manufacturing setting. The company values safety, structure, and continuous improvement, with a strong emphasis on safety, health, and environmental responsibility. They have implemented international standards such as ISO and conduct monthly on-site safety inspections. The culture values visibility, accountability, and direct leadership.</p>

<h1><strong>Quality Manager</strong></h1><p><br></p><h2>Job Description</h2><p>The Quality Manager will play a critical role in ensuring that all products meet safety, quality, and regulatory standards before they reach customers.</p><p><br></p><h2>Responsibilities</h2><ul><li>Develop, implement, and maintain quality assurance protocols and SOPs.</li><li>Supervise lab testing of finished products including alcolizer, pH, CO2, nitrogen, and carbonation.</li><li>Assist in obtaining SQF and GMP certifications.</li><li>Maintain documentation and traceability for all quality-related activities.</li><li>Manage and train QA Technicians.</li><li>Collaborate closely with the production team.</li><li>Address customer complaints and implement corrective actions.</li><li>Ensure co-packed products meet client specifications and expectations.</li><li>Source lab equipment and work with vendors.</li><li>Understand the blending process.</li><li>Implement Sensory panel testing for products.</li></ul><h2>Essential Skills</h2><ul><li>Quality assurance</li><li>Food safety</li><li>Food quality</li><li>Audit</li><li>SQF</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor&#39;s degree in Food Science, Microbiology, Chemistry, or related field</li><li>3+ years in QA/QC roles in the beverage or food industry</li></ul><h2>Work Environment</h2><p>The main facility is a brewery featuring a 2,200 sq ft warehouse with one production line and six 9,000-gallon tanks for blending. There is also a 4,400 sq ft packaging warehouse. The company is growing rapidly and is involved in packing products for established brands.</p>

<p><strong>Description</strong></p>
					<p>	Ensure facility compliance with cGMP regulations (21 CFR Part 111 for dietary supplements, 21 CFR 210/211 for OTC drugs if applicable, and ISO 22716 for skin care).
	Maintain and oversee the Quality Management System (QMS), including SOPs, work instructions, and quality manuals.
	Manage regulatory inspections (FDA, state, third-party audits) and coordinate responses to findings.
	Stay updated on relevant regulatory changes and ensure facility compliance.
	Review and approve Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) for accuracy and compliance.
	Oversee and approve in-process checks (pH, viscosity, microbial limits, fill weights).
	Ensure that line clearance and changeover procedures are properly executed.
	Supervise incoming raw material testing (identity, potency, microbiological, heavy metals if applicable).
	Oversee finished product testing to ensure products meet specifications.
	Review and approve Certificates of Analysis (CoA) from third-party labs.
	Approve and maintain the Approved Supplier Program.
	Conduct supplier qualifications, audits, and periodic reviews.
	Ensure proper raw material traceability and adherence to quality specifications.
	Investigate deviations, non-conformances, and customer complaints.
	Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA).
	Manage change control for processes, materials, and equipment affecting product quality.
	Train staff on cGMP, SOPs, hygiene, and quality standards.
	Maintain training records and ensure ongoing competency of production and quality teams.
	Ensure proper documentation practices (GDP).
	Maintain and archive all quality records, batch documentation, and testing results per regulatory requirements.
	Monitor and ensure compliance with sanitation and cleaning validation protocols.

	Oversee environmental monitoring for microbial contamination (particularly for liquid products).
	Make final product disposition decisions (release, reject, or hold).
	Participate in product recall investigations and ensure recall procedures are in place.
	Identify process improvements to enhance product quality, efficiency, and compliance.
	Participate in cross-functional meetings to ensure quality considerations are integrated into production planning.</p>
					<p><strong>Skills</strong></p>
					<p>Gmp, fda, audit, cgmp</p>
					
					
					<p><strong>Additional Skills &amp; Qualifications</strong></p>
					<p>-	Knowledge of Excel, Word, and Adobe software.
-	Communication and management skills.
-	Ability to manage, carryout, and prioritize departmental functions.
-	Ability to see areas that need improvement and to address them.
-	Extensive <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">background</span></span></span></span></span></span> in quality systems and food and beverage manufacture.</p>
					<p><strong>Experience Level</strong></p>
					<p>Expert Level</p>

Quality Operations Manager

<h1 style="font-weight: 700;">Job Title: Quality Operations Manager</h1><br><h2>Job Description</h2><p>As a Quality Operations Manager, you will ensure facility compliance with cGMP regulations, oversee the Quality Management System, manage regulatory inspections, and stay updated on relevant regulatory changes. You will be responsible for maintaining high standards in quality management and regulatory compliance across all operations.</p><br><h2>Responsibilities</h2><ul><li>Ensure facility compliance with cGMP regulations for dietary supplements, OTC drugs, and skin care.</li><li>Maintain and oversee the Quality Management System, including SOPs, work instructions, and quality manuals.</li><li>Manage regulatory inspections and coordinate responses to findings.</li><li>Stay updated on relevant regulatory changes and ensure facility compliance.</li><li>Review and approve Master Manufacturing Records and Batch Production Records for accuracy and compliance.</li><li>Oversee and approve in-process checks such as pH, viscosity, microbial limits, and fill weights.</li><li>Ensure proper execution of line clearance and changeover procedures.</li><li>Supervise incoming raw material testing for identity, potency, microbiological content, and heavy metals.</li><li>Oversee finished product testing to ensure products meet specifications.</li><li>Review and approve Certificates of Analysis from third-party labs.</li><li>Approve and maintain the Approved Supplier Program, conducting supplier qualifications, audits, and periodic reviews.</li><li>Ensure proper raw material traceability and adherence to quality specifications.</li><li>Investigate deviations, non-conformances, and customer complaints.</li><li>Lead root cause analysis and implement Corrective and Preventive Actions.</li><li>Manage change control for processes, materials, and equipment affecting product quality.</li><li>Train staff on cGMP, SOPs, hygiene, and quality standards, maintaining training records.</li><li>Ensure proper documentation practices and archive all quality records per regulatory requirements.</li><li>Monitor and ensure compliance with sanitation and cleaning validation protocols.</li><li>Oversee environmental monitoring for microbial contamination, particularly for liquid products.</li><li>Make final product disposition decisions, including release, reject, or hold.</li><li>Participate in product recall investigations and ensure recall procedures are in place.</li><li>Identify process improvements to enhance product quality, efficiency, and compliance.</li><li>Participate in cross-functional meetings to integrate quality considerations into production planning.</li></ul><h2>Essential Skills</h2><ul><li>Operations management experience leading both Quality Assurance and Quality Control departments.</li><li>10 years of experience in quality operations within the food and beverage sector.</li><li>5 years of management experience in the quality operations of the food and beverage sector, preferably dietary supplements.</li><li>4-Year degree in Food Science or equivalent field.</li><li>Excellent communication and management skills.</li><li>Ability to manage, carry out, and prioritize departmental functions.</li><li>Extensive <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">background</span></span> in quality systems and food and beverage manufacture.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Knowledge of Excel, Word, and Adobe software.</li><li>Driven, organized, and detail-oriented individual.</li><li>Ability to see areas that need improvement and address them.</li></ul><h2>Work Environment</h2><p>This role encompasses facility-wide operations, including warehousing, shipping, receiving, manufacturing, packaging, and QC labs, ensuring a comprehensive approach to quality management.</p><br>

<p><strong>Description</strong></p><ul><li>Independently initiate, investigate, and complete Minor and low/medium severity Major deviations.</li><li>Collaboratively support high severity Major and Critical deviations under supervision.</li><li>Translate complex scientific events into clear, concise, and cohesive technical reports.</li><li>Conduct Root Cause Analysis (RCA), risk assessments, and impact evaluations on product quality (SISQP).</li><li>Identify and implement Corrective and Preventive Actions (CAPAs) to prevent recurrence.</li><li>Perform data gathering, trend analysis, cause mapping, and associate interviews.</li><li>Facilitate and participate in cross-functional meetings, alignment sessions, and deviation review boards.</li><li>Communicate investigation status and outcomes to internal teams and external clients through presentations and reports.</li><li>Work on the manufacturing floor to observe processes and collect data for investigations.</li><li>Manage multiple investigations and timelines, escalating issues as needed to ensure timely resolution.</li></ul><p><br></p><p><strong>Skills</strong></p><ul><li>Laboratory, Biology, Gmp, Quality control, Microbiology</li></ul><p><strong>Top Skills Details</strong></p><ul><li>Laboratory,Biology,Gmp</li></ul><p><strong>Additional Skills &amp; Qualifications</strong></p><ul><li>Bachelor’s degree in a scientific or technical discipline required.</li><li>3+ years of experience in a GMP-regulated environment, preferably in manufacturing or quality.</li><li>Strong technical writing skills with the ability to communicate complex topics to a broad audience.</li><li>Proficient in root cause analysis tools, risk assessment methodologies, and deviation management systems.</li><li>Experience with client-facing communication, including presentations and facilitated reviews.</li><li>Ability to manage multiple priorities in a fast-paced, cross-functional environment.</li></ul><p><br></p><p><br></p><p>Preferred Skills:</p><ul><li>Experience with TrackWise or similar quality management systems.</li><li>Strong facilitation and conflict resolution skills.</li><li>Familiarity with SISQP principles and regulatory compliance standards.</li><li>Positive, proactive, and adaptable mindset with a focus on continuous improvement.</li></ul><p><strong>Experience Level</strong></p><ul><li>Intermediate Level</li></ul>

Quality Records Investigtor

<p><strong>Quality Specialist </strong></p><p><br></p><p><strong><u>Job Description </u></strong></p><ul><li>Manage and lead all activities associated with the creation, implementation and maintenance of the ISO9001 IATF16949 Quality System</li><li>Ensure training is provided to all personnel within the organization for ISO 9001 / IATF16949 System Requirements</li><li>Facilitate the integration of UES Quality Standards into the QMS</li><li>Promote the company quality policy and the organizational goals of the company</li><li>Assist all areas/departments as needed in developing procedures, work instructions and required documentation</li><li>Coordinate all activities associated with the third party registrar, pre-assessment, initial and surveillance audits</li><li>Ensure that all corrective actions related to non-conformances identified in a third party audit are addressed, processed and verified</li><li>Ensure that the internal audit schedule reviews all elements of the QMS and UES Quality Standards and confirm that the QMS is effectively implemented; Establish firm resolution of internal findings</li><li>Ensure QMS training of all internal auditors and potential corrective action assignees is complete and effective</li><li>Lead the maintenance of the QMS software system and provide technical support</li><li>Audit the effectiveness of root cause analysis of CARs; Provide leadership in the development and implementation of irreversible countermeasures</li><li>Evaluate QMS countermeasures for effectiveness prior to presentation to customer or other auditor</li><li>Participate in Customer audits as required, as well as nonconformance closure activities</li><li>Develop and administer layered process auditing within Portland and Smyrna facilities</li><li>Maintain quality tracking charts as requested</li><li>Prepare necessary metrics, reporting, and presentations for Quality Meetings</li><li>Enter requisitions as needed for PO creation</li></ul><p><strong><u>Qualifications:</u></strong></p><ul><li>Previous Quality Management Systems experience (ideally within the automotive industry)</li><li>Certification as ISO/IATF16949</li><li>5+ years experience in the quality assurance field</li><li>2+ years experience in ISO/TS16949 Implementation</li><li>Prior experience working with Third Party Registrars</li></ul><p><br></p>

Quality Specialist

<h1 style="font-weight: 700;">Job Title: Quality Specialist - Validation</h1><br><h2>Job Description</h2><p>The Quality Specialist - Validation ensures adherence to current Good Manufacturing Practices (cGMP) and FDA Quality Systems throughout the evaluation, review, and approval of validation and quality assurance/control documentation. This role is essential in maintaining high-quality standards and compliance within the organization.</p><br><h2>Responsibilities</h2><ul><li>Assist in the development of cGMP operating procedures related to process, computer systems, and equipment validation.</li><li>Assure compliance with SOPs upon implementation and investigate additional corrective actions as needed.</li><li>Communicate with Field Quality/Operations and other personnel regarding Donor Center compliance and cGMP issues.</li><li>Ensure validation approaches align with regulatory expectations and industry standards.</li><li>Write and execute test cases to validate critical control points, user requirements, and functional designs.</li><li>Interact with Donor Center and Field Quality/Operations personnel to facilitate validation testing, ensuring timely and documented approval prior to routine use.</li><li>Analyze validation data to ensure acceptance criteria are met and assist in writing validation summaries.</li><li>Ensure milestones and timelines are met on assigned projects and prepare validation reports for distribution.</li><li>Evaluate adequacy of corrective actions and participate in the evaluation of processes, systems, and equipment needs.</li><li>Prepare validation equipment for use at the Donor Center and evaluate upon return.</li><li>Identify and determine actions for adding, removing, and/or revalidating processes, systems, and equipment.</li><li>Track and monitor process/system failures/events and provide feedback to Donor Center management.</li><li>Monitor and trend customer complaints and nonconformance related to equipment failures.</li></ul><h2>Essential Skills</h2><ul><li>Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.</li><li>Excellent quantitative and analytical skills.</li><li>Exceptional oral and written communication skills.</li><li>Strong critical thinking and problem-solving abilities.</li><li>Ability to identify errors and provide corrective action.</li><li>Proficient in Microsoft Office applications and computer applications used in the field.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor&#39;s degree.</li></ul><h2>Work Environment</h2><p>The work is performed in both office and laboratory/manufacturing environments with exposure to biological fluids and potential infectious organisms. There is occasional exposure to extreme cold and high noise levels in production areas, as well as electrical office and laboratory equipment. Personal protective equipment, such as protective eyewear, garments, and gloves, is required. The role involves sitting for 4-6 hours daily, with occasional standing, bending, and twisting. Repetitive hand movements and precise coordinated finger movements are necessary. Lifting and carrying objects up to 50lbs may be required. Near and far vision correctable in one eye to 20/30 and to 20/100 in the other eye is essential. The ability to communicate complex information effectively and follow instructions is crucial.</p><br>

Quality Specialist - Validation

<h1><strong>Quality Specialist - Validation</strong></h1><p><br></p><h2>Job Description</h2><p>The Quality Specialist - Validation ensures adherence to current Good Manufacturing Practices (cGMP) and FDA Quality Systems throughout the evaluation, review, and approval of validation and quality assurance/control documentation. This role is essential in maintaining high-quality standards and compliance within the organization.</p><p><br></p><h2>Responsibilities</h2><ul><li>Assist in the development of cGMP operating procedures related to process, computer systems, and equipment validation.</li><li>Assure compliance with SOPs upon implementation and investigate additional corrective actions as needed.</li><li>Communicate with Field Quality/Operations and other personnel regarding Donor Center compliance and cGMP issues.</li><li>Ensure validation approaches align with regulatory expectations and industry standards.</li><li>Write and execute test cases to validate critical control points, user requirements, and functional designs.</li><li>Interact with Donor Center and Field Quality/Operations personnel to facilitate validation testing, ensuring timely and documented approval prior to routine use.</li><li>Analyze validation data to ensure acceptance criteria are met and assist in writing validation summaries.</li><li>Ensure milestones and timelines are met on assigned projects and prepare validation reports for distribution.</li><li>Evaluate adequacy of corrective actions and participate in the evaluation of processes, systems, and equipment needs.</li><li>Prepare validation equipment for use at the Donor Center and evaluate upon return.</li><li>Identify and determine actions for adding, removing, and/or revalidating processes, systems, and equipment.</li><li>Track and monitor process/system failures/events and provide feedback to Donor Center management.</li><li>Monitor and trend customer complaints and nonconformance related to equipment failures.</li></ul><h2>Essential Skills</h2><ul><li>Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.</li><li>Excellent quantitative and analytical skills.</li><li>Exceptional oral and written communication skills.</li><li>Strong critical thinking and problem-solving abilities.</li><li>Ability to identify errors and provide corrective action.</li><li>Proficient in Microsoft Office applications and computer applications used in the field.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor&#39;s degree.</li></ul><h2>Work Environment</h2><p>The work is performed in both office and laboratory/manufacturing environments with exposure to biological fluids and potential infectious organisms. There is occasional exposure to extreme cold and high noise levels in production areas, as well as electrical office and laboratory equipment. Personal protective equipment, such as protective eyewear, garments, and gloves, is required. The role involves sitting for 4-6 hours daily, with occasional standing, bending, and twisting. Repetitive hand movements and precise coordinated finger movements are necessary. Lifting and carrying objects up to 50lbs may be required. Near and far vision correctable in one eye to 20/30 and to 20/100 in the other eye is essential. The ability to communicate complex information effectively and follow instructions is crucial.</p>

<h1><strong><u>Quality Systems Engineering Opportunity! </u></strong></h1><p><strong><em>For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.comwith the following:</em></strong></p><p><strong>1) Word copy of resume</strong></p><p><strong>2) 2-3 professional references</strong></p><p><strong>3) 4-5 brief bullet points highlighting technical qualifications</strong></p><p><br></p><h2>Job Description</h2><p>We are seeking a highly experienced Level III Quality Systems Engineer to join our Quality and Regulatory team. This role is critical in ensuring the integrity and compliance of marketing claims associated with our medical devices. The ideal candidate will have a strong <span style="color: rgb(8, 7, 7); background-color: none;">background</span> in quality systems within the medical device industry and a proven ability to trace marketing claims to supporting engineering analyses and documentation. This individual will also be responsible for developing and maintaining SOPs related to the establishment and validation of marketing claims, with a focus on different user populations. Additionally, this role will involve collecting and reviewing existing documentation to identify and substantiate claims, and later, training key stakeholders on the newly developed claims process to ensure consistent understanding and implementation across the organization.</p><p><br></p><h2>Responsibilities</h2><ul><li>Collect and review existing internal documentation to identify potential marketing claims.</li><li>Organize and document findings to support traceability and validation efforts with internal project team.</li><li>Investigate and validate marketing claims by tracing them to engineering analyses, risk assessments, and supporting technical documentation.</li><li>Evaluate claims for accuracy, scientific validity, and compliance with regulatory standards.</li><li>Assess claims made for different user populations to ensure appropriate substantiation.</li><li>Utilize Pepper Flow software to manage and maintain traceability of claims to source documentation.</li><li>Ensure all documentation is audit-ready and compliant with internal and external quality standards.</li><li>Develop, implement, and maintain Standard Operating Procedures (SOPs) for the creation, review, and approval of marketing claims.</li><li>Collaborate with cross-functional teams (Marketing, R&amp;D, Regulatory, Clinical) to align SOPs with business and compliance needs.</li><li>Partner with Regulatory Affairs to ensure claims meet global regulatory requirements.</li><li>Work closely with Engineering and Clinical teams to gather and interpret data supporting claims.</li><li>Provide training and guidance to internal stakeholders on claim substantiation processes.</li><li>Design and deliver training sessions for key stakeholders on the new claims process.</li><li>Ensure consistent understanding and adoption of the process across relevant departments.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).</li><li>8–10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry.</li><li>Strong understanding of FDA regulations and other relevant standards.</li><li>Experience with Pepper Flow or similar document control/traceability systems.</li><li>Demonstrated ability to critically evaluate scientific and engineering data.</li><li>Excellent written and verbal communication skills.</li><li>Strong organizational and project management skills.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Familiarity with global regulatory environments (e.g., EU MDR, Health Canada).</li><li>Prior experience developing SOPs and quality documentation.</li><li>Knowledge of human factors and usability engineering as it relates to different user populations.</li></ul><h2>Work Environment</h2><p>This position is onsite in Irvine, CA. The role offers a dynamic work environment where collaboration with cross-functional teams is key. Benefits include 2 weeks PTO and 10 client-paid holidays</p>

Quality Systems Engineer

<h2>Responsibilities</h2><ul><li>Support IATF auditing by leading internal and external audits and ensuring audit readiness.</li><li>Develop and maintain quality documentation including control plans, PFMEAs, process flows, and inspection instructions.</li><li>Coordinate and execute APQP and PPAP activities for new product launches and annual re-validations.</li><li>Manage document control systems and calibration programs for gages and equipment.</li><li>Lead root cause analysis and corrective action processes (8D, 5-Why, Fishbone) for internal and customer quality issues.</li><li>Support layered audits and manage corrective actions stemming from audit findings.</li></ul><h2>Essential Skills</h2><ul><li>Associate or Bachelor’s degree in Engineering, Quality, or a related field; equivalent experience considered.</li><li>2–5 years of experience in quality systems engineering.</li><li>Strong knowledge of IATF, ISO 9001, and related quality standards.</li><li>Experience in audit scheduling, execution, and follow-up.</li><li>Proficiency in quality tools such as SPC, MSA, GD&amp;T, and CMM programming.</li></ul>

<h1><strong><u>Quality Systems Engineering Opportunity! </u></strong></h1><p><strong><u>** For Immediate consideration please apply to this posting and email your resume to habels@actalentservices.com** </u></strong></p><p><br></p><h2>Job Description</h2><p>We are seeking a highly experienced Level III Quality Systems Engineer to join our Quality and Regulatory team. This role is critical in ensuring the integrity and compliance of marketing claims associated with our medical devices. The ideal candidate will have a strong <span style="color: rgb(8, 7, 7); background-color: none;">background</span> in quality systems within the medical device industry and a proven ability to trace marketing claims to supporting engineering analyses and documentation. This individual will also be responsible for developing and maintaining SOPs related to the establishment and validation of marketing claims, with a focus on different user populations. Additionally, this role will involve collecting and reviewing existing documentation to identify and substantiate claims, and later, training key stakeholders on the newly developed claims process to ensure consistent understanding and implementation across the organization.</p><p><br></p><h2>Responsibilities</h2><ul><li>Collect and review existing internal documentation to identify potential marketing claims.</li><li>Organize and document findings to support traceability and validation efforts with internal project team.</li><li>Investigate and validate marketing claims by tracing them to engineering analyses, risk assessments, and supporting technical documentation.</li><li>Evaluate claims for accuracy, scientific validity, and compliance with regulatory standards.</li><li>Assess claims made for different user populations to ensure appropriate substantiation.</li><li>Utilize Pepper Flow software to manage and maintain traceability of claims to source documentation.</li><li>Ensure all documentation is audit-ready and compliant with internal and external quality standards.</li><li>Develop, implement, and maintain Standard Operating Procedures (SOPs) for the creation, review, and approval of marketing claims.</li><li>Collaborate with cross-functional teams (Marketing, R&amp;D, Regulatory, Clinical) to align SOPs with business and compliance needs.</li><li>Partner with Regulatory Affairs to ensure claims meet global regulatory requirements.</li><li>Work closely with Engineering and Clinical teams to gather and interpret data supporting claims.</li><li>Provide training and guidance to internal stakeholders on claim substantiation processes.</li><li>Design and deliver training sessions for key stakeholders on the new claims process.</li><li>Ensure consistent understanding and adoption of the process across relevant departments.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).</li><li>8–10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry.</li><li>Strong understanding of FDA regulations and other relevant standards.</li><li>Experience with Pepper Flow or similar document control/traceability systems.</li><li>Demonstrated ability to critically evaluate scientific and engineering data.</li><li>Excellent written and verbal communication skills.</li><li>Strong organizational and project management skills.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Familiarity with global regulatory environments (e.g., EU MDR, Health Canada).</li><li>Prior experience developing SOPs and quality documentation.</li><li>Knowledge of human factors and usability engineering as it relates to different user populations.</li></ul><h2>Work Environment</h2><p>This position is onsite in Irvine, CA. The role offers a dynamic work environment where collaboration with cross-functional teams is key. Benefits include 2 weeks PTO and 10 client-paid holidays.</p>

<h1 style="font-weight: 700;">Job Title: Quality Systems Engineer</h1><br><h2>Job Description</h2><p>We are seeking a highly experienced Level III Quality Systems Engineer to join our Quality and Regulatory team. This role is critical in ensuring the integrity and compliance of marketing claims associated with our medical devices. The ideal candidate will have a strong <span style="color: rgb(8, 7, 7); background-color: none;">background</span> in quality systems within the medical device industry and a proven ability to trace marketing claims to supporting engineering analyses and documentation. This individual will also be responsible for developing and maintaining SOPs related to the establishment and validation of marketing claims, with a focus on different user populations. Additionally, this role will involve collecting and reviewing existing documentation to identify and substantiate claims, and later, training key stakeholders on the newly developed claims process to ensure consistent understanding and implementation across the organization.</p><br><h2>Responsibilities</h2><ul><li>Collect and review existing internal documentation to identify potential marketing claims.</li><li>Organize and document findings to support traceability and validation efforts with the internal project team.</li><li>Investigate and validate marketing claims by tracing them to engineering analyses, risk assessments, and supporting technical documentation.</li><li>Evaluate claims for accuracy, scientific validity, and compliance with regulatory standards.</li><li>Assess claims made for different user populations to ensure appropriate substantiation.</li><li>Utilize Pepper Flow software to manage and maintain traceability of claims to source documentation.</li><li>Ensure all documentation is audit-ready and compliant with internal and external quality standards.</li><li>Develop, implement, and maintain Standard Operating Procedures (SOPs) for the creation, review, and approval of marketing claims.</li><li>Collaborate with cross-functional teams to align SOPs with business and compliance needs.</li><li>Partner with Regulatory Affairs to ensure claims meet global regulatory requirements.</li><li>Work closely with Engineering and Clinical teams to gather and interpret data supporting claims.</li><li>Provide training and guidance to internal stakeholders on claim substantiation processes.</li><li>Design and deliver training sessions for key stakeholders on the new claims process.</li><li>Ensure consistent understanding and adoption of the process across relevant departments.</li></ul><h2>Essential Skills</h2><ul><li>Strong <span style="color: rgb(8, 7, 7); background-color: none;">background</span> in quality systems within the medical device industry.</li><li>Ability to trace marketing claims to supporting engineering analyses and documentation.</li><li>Understanding of FDA regulations and other relevant standards.</li><li>Experience with Pepper Flow or similar document control/traceability systems.</li><li>Ability to critically evaluate scientific and engineering data.</li><li>Excellent written and verbal communication skills.</li><li>Strong organizational and project management skills.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).</li><li>8–10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry.</li><li>Familiarity with global regulatory environments.</li><li>Prior experience developing SOPs and quality documentation.</li><li>Knowledge of human factors and usability engineering as it relates to different user populations.</li></ul><h2>Work Environment</h2><p>This position is based onsite in Irvine, CA. Employees enjoy two weeks of paid time off and ten client-paid holidays.</p><br>

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