<h1 style="text-align: center;"><strong>Hiring for a Quality Engineer in West Hartford!</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking skilled Quality Engineers to join our expanding quality department. With two immediate openings, we are looking for candidates who possess a strong machining <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">background</span></span> to contribute to our team.</p><p><br></p><h2>Responsibilities</h2><ul><li>Utilize ISO9001 and AS9100 standards in quality engineering practices.</li><li>Conduct root cause analysis to identify issues and implement effective solutions.</li><li>Perform supplier audits to ensure compliance and help build new supplier programs.</li><li>Engage in audits and regulatory compliance activities to uphold quality standards.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in quality engineering and quality assurance.</li><li>Experience with root cause analysis and supplier quality management.</li><li>Knowledge of ISO9001 and AS9100 quality management systems.</li><li>Machining skills and familiarity with CMM.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Familiarity with Windchill, Epicor, and Microsoft Office software.</li><li>Experience with quality management systems, particularly on Microsoft platforms.</li></ul><h2>Work Environment</h2><p>Join a historic company poised for growth with numerous upcoming contracts. Take advantage of new management and the opportunity to make a significant impact</p>

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Quality Engineer

<h1><strong>Job Title: Process Chemical Engineer</strong></h1><p><br></p><h2>Job Description</h2><p>Develops and utilizes key process indicators and statistical methods to determine process effectiveness, identify areas for improvement, best practices, and lead teams in driving continuous quality improvement. Leads, drives, and supports corrective and preventive actions, and effectiveness verification activities for product quality issues and customer complaints. Ensures that quality reporting and records related to incoming and in-process quality trends, returns analysis, complaint investigation, and corrective action activity are clearly documented and maintained.</p><p><br></p><h2>Responsibilities</h2><ul><li>Develop and use key process indicators and statistical methods to assess process effectiveness.</li><li>Identify areas for improvement and implement best practices.</li><li>Lead teams in driving continuous quality improvement.</li><li>Support and drive corrective and preventive actions for product quality issues.</li><li>Verify the effectiveness of corrective and preventive actions.</li><li>Document and maintain quality reporting and records related to incoming and in-process quality trends.</li><li>Analyze returns and investigate complaints.</li><li>Ensure corrective action activities are clearly documented and maintained.</li></ul><h2>Essential Skills</h2><ul><li>B.S. degree in Chemical Engineering.</li><li>1 - 3 years of experience in a manufacturing environment with a focus on product quality.</li><li>Proficiency in Six Sigma methodologies.</li><li>Strong skills in root cause analysis.</li><li>Experience in process improvement.</li><li>Experience in chemical manufacturing.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Knowledge of the Automotive Quality Standard IATF (or earlier versions) is a plus.</li></ul><h2>Work Environment</h2><p>The work environment includes developing a pilot plant to manufacture a new product, which will be a multimillion-dollar project. Operations include a diverse market such as consumer products, pharmaceuticals, and automotive industries, providing a dynamic and varied work experience.</p>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>Lead the Quality Review Board process and collaborate with other technical leads to investigate, understand, and resolve customer feedback issues. Work closely with engineering, manufacturing, product management, quality, and supplier quality teams to understand customer and product requirements, design intent, and manufacturing processes to develop root cause of failure. Create, maintain, and report key performance measures (KPIs).</p><br><h2>Responsibilities</h2><ul><li>Lead Quality Review Board process.</li><li>Receive customer feedback and collaborate with other technical leads to resolve issues.</li><li>Collaborate with engineering, manufacturing, product management, quality, and supplier quality teams to understand requirements and develop root cause of failure.</li><li>Create, maintain, and report key performance measures (KPIs).</li></ul><h2>Essential Skills</h2><ul><li>Quality engineering</li><li>Problem solving</li><li>Root cause analysis</li><li>Bachelor&#39;s degree in Mechanical Engineering or related field</li><li>2+ years of related quality engineering experience</li><li>Experience working with customers or suppliers</li><li>Six Sigma</li><li>8D problem solving</li><li>Project management</li><li>Process engineering</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>5+ years of experience in a manufacturing setting preferred</li><li>Process Engineering experience is a plus</li><li>Refrigeration experience would be a plus</li><li>Strong problem-solving and analytical capability</li><li>Detail-oriented</li><li>Ability to assess product performance and develop root cause analysis and initial problem solving</li></ul><h2>Work Environment</h2><p>The role involves working 1/3 of the time at customer sites in the field, 1/3 in the factory with engineering, supplier quality, and project management teams, and 1/3 working independently on processes or reports. The position requires running a cross-functional team and quality council, including weekly meetings to discuss field data and problem-solving strategies. Travel across the US and Canada is required to support North American customers.</p><br>

<h1><strong>Job Title: Quality Engineer</strong></h1><p><br></p><h2>Job Description</h2><p>The Quality Engineer will perform routine analysis on quality problems identified within the manufacturing process and resolve them through the application of acquired expertise guided by precedent. The role involves establishing and executing project quality plans, witness-points, and quality records for compliance with contract requirements, ensuring customer quality requirements and lessons learned are considered when analyzing proposed changes to improve processes. Additionally, the Quality Engineer will develop new solutions under guidance or in a team setting, collaborate with cross-functional teams to solve production quality problems, and deliver products as part of a team while performing analytical activities and maintaining quality metrics related to production quality.</p><p><br></p><h2>Responsibilities</h2><ul><li>Perform routine analysis on quality problems within the manufacturing process.</li><li>Resolve issues using acquired expertise guided by precedent.</li><li>Establish and execute project quality plans for compliance with contract requirements.</li><li>Ensure customer quality requirements and feedback are considered in process improvements.</li><li>Develop new solutions under guidance or in team settings.</li><li>Collaborate with cross-functional teams to solve production quality problems.</li><li>Deliver products as part of a team.</li><li>Perform analytical activities and maintain quality metrics related to production quality.</li></ul><h2>Essential Skills</h2><ul><li>Quality engineering knowledge.</li><li>Understanding of quality standards.</li><li>Experience with lean manufacturing techniques.</li><li>Bachelor&#39;s degree in Engineering (Mechanical, Industrial, Electrical).</li><li>Minimum of 2 years of experience in Manufacturing Quality.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience with developing solutions in team settings.</li><li>Ability to collaborate with cross-functional teams.</li></ul><h2>Work Environment</h2><ul><li>The position is onsite five days a week.</li></ul>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>Assure product quality from design through assembly operations. Provide leadership in failure analysis and corrective action to prevent defects from happening in the manufacturing and assembly operations. The Quality Engineer will also serve as a quality representative, providing input on the manufacturability and serviceability of designs. Utilizing failure and defect reports, the role will assist in making recommendations to improve quality.</p><br><h2>Responsibilities</h2><ul><li>Perform failure and defect analysis in cooperation with Engineering and Manufacturing to determine appropriate corrective actions for quality problems and follow-up to ensure these actions are implemented.</li><li>Conduct in-process audits to identify production problems before products are submitted to Final Inspection.</li><li>Plan and execute quality measures for incoming material, manufactured components, assemblies, and finished products.</li><li>Assist in establishing effective inspection sampling plans and quality audits to ensure cost-effective compliance with customer expectations and specifications.</li></ul><h2>Essential Skills</h2><ul><li>3-5 years of experience in quality engineering with a focus on manufacturing quality and process improvement.</li><li>Proficiency in PPAP, root cause analysis, and statistical process control (SPC).</li><li>Strong understanding of quality standards, quality control, and quality assurance.</li><li>Experience in conducting audits and statistical analysis.</li><li>Bachelor&#39;s degree in Engineering or a related field.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Training in SPC and other quality tools used for process improvement.</li><li>Knowledge of SCAR, CAPA, CpK, PPAP, control plans, and non-conformance management.</li></ul><h2>Work Environment</h2><p>The position is based in a clean facility and involves a mix of desk work and on-the-floor activities. The Quality Engineer will have a dedicated desk and will use various tools to manage suppliers and improve supplier performance.</p><br>

<h1><strong>Job Title: Quality Engineer - NPI</strong></h1><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 through technical leadership and direction 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, including pFMEA. Your role will involve developing and characterizing processes that are capable, scalable, and produce high yield, as well as supporting the design of robust inspection strategies including CQA&#39;s, CTQ&#39;s, and MSA&#39;s. You will provide quality engineering support for the execution of quality assurance activities during the design transfer phases of new product development.</p><p><br></p><h2>Responsibilities</h2><ul><li>Foster collaborative internal and external professional relationships across Design Divisions, Advanced Operations, and GQO functions associated with design transfer activities.</li><li>Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet NPI project goals.</li><li>Mentor other groups and functions on areas of expertise, particularly focusing on design and process transfer.</li><li>Develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products are free of flaws and function as designed.</li><li>Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates.</li><li>Analyze reports and defective products to determine trends and recommend corrective actions.</li><li>Collaborate with supplier representatives on quality problems, ensure effective corrective actions are implemented, and contribute to supplier quality improvement programs.</li><li>Proficient in risk management practices and tools, with high expertise in failure modes associated with production and production-related processes (PFMEA).</li><li>Support the Risk Management File through risk management principles, evaluating process risks, risk mitigation, and ensuring appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle through robust pFMEA.</li><li>Ensure all Risk Management outputs comply with ISO14971.</li><li>Support the design team to complete CQA/CTQ identification and inputs to dFMEA to enable process risk identification, process characterization, process capability, and robust process control.</li><li>Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies, ensuring inspections are repeatable, efficient, and scalable.</li><li>Lead continuous improvements of inspection methods and sampling plans, focusing on human error risk elimination.</li><li>Lead First Article Inspection (FAI) strategies, both internally and externally, and approve First Article Inspections.</li><li>Optimize inspection costs through lean initiatives while maintaining the safety, integrity, and reliability of the product.</li><li>Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.</li><li>Support the development, execution, and approval of validation strategies with the goal of highly capable processes that result in high yield and enable scalability.</li><li>Approve protocols and reports, including data analysis.</li><li>Influence processes towards validation versus manual verification, where possible.</li><li>Support sterilization validation activity, as required.</li><li>Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.</li><li>Provide expertise for NC&#39;s &amp; CAPA&#39;s related to new products, acting as a subject matter expert and mentor in problem-solving and root-causing tools.</li><li>Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies, and tooling &amp; fixture development.</li><li>Support ‘process benchmarking’ by providing quality experience as a process input.</li><li>Promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation.</li><li>Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).</li><li>Ensure Supplier’s Quality Systems can complete process characterization and develop highly capable processes that are scalable.</li><li>Provide Quality input to influence the proper selection of suppliers.</li><li>Support implementation of supplier certification.</li><li>Support Supplier Quality to establish Quality Agreements with sites and suppliers as part of NPI projects.</li><li>Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets.</li><li>Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal &amp; external audits with regulatory representatives.</li><li>Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.</li><li>Support device design into production specifications.</li><li>Lead the efficient and timely transfer of lessons learned knowledge to Quality engineering support and regional peers.</li><li>Provide expert quality process support post-launch per DTAP agreement.</li><li>Support the control of product through appropriate system containment to guard against product escape during pre-released builds.</li></ul><h2>Essential Skills</h2><ul><li>Experience in ISO standards, Design Transfer, Manufacturing, Risk Management, NPI, PFMEA, Validation, Quality engineering, Medical device, Design Control, and Product Transfer.</li><li>Bachelor of Science in Engineering or related subject.</li><li>3-5 years&#39; experience in a quality or technical discipline.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Knowledge of CQA, CTQ, ISO14971, MSA, and PFMEA.</li><li>This role requires the use of judgment in applying professional expertise and working independently with minimal supervision.</li></ul><h2>Work Environment</h2><p>This position is onsite and offers standard benefits, including 2 weeks of PTO and 10 paid holidays. The work environment promotes collaboration and continuous improvement, focusing on maintaining high quality standards in a dynamic setting.</p>

Quality Engineer - NPI

<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.com with 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>As a Quality Engineer specializing in New Product Introduction (NPI), you will advocate and lead design for manufacture and assembly through technical leadership and direction 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, including pFMEA. Your role will involve developing and characterizing processes that are capable, scalable, and produce high yield, as well as supporting the design of robust inspection strategies including CQA&#39;s, CTQ&#39;s, and MSA&#39;s. You will provide quality engineering support for the execution of quality assurance activities during the design transfer phases of new product development.</p><p><br></p><h2>Responsibilities</h2><ul><li>Foster collaborative internal and external professional relationships across Design Divisions, Advanced Operations, and GQO functions associated with design transfer activities.</li><li>Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet NPI project goals.</li><li>Mentor other groups and functions on areas of expertise, particularly focusing on design and process transfer.</li><li>Develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products are free of flaws and function as designed.</li><li>Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates.</li><li>Analyze reports and defective products to determine trends and recommend corrective actions.</li><li>Collaborate with supplier representatives on quality problems, ensure effective corrective actions are implemented, and contribute to supplier quality improvement programs.</li><li>Proficient in risk management practices and tools, with high expertise in failure modes associated with production and production-related processes (PFMEA).</li><li>Support the Risk Management File through risk management principles, evaluating process risks, risk mitigation, and ensuring appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle through robust pFMEA.</li><li>Ensure all Risk Management outputs comply with ISO14971.</li><li>Support the design team to complete CQA/CTQ identification and inputs to dFMEA to enable process risk identification, process characterization, process capability, and robust process control.</li><li>Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies, ensuring inspections are repeatable, efficient, and scalable.</li><li>Lead continuous improvements of inspection methods and sampling plans, focusing on human error risk elimination.</li><li>Lead First Article Inspection (FAI) strategies, both internally and externally, and approve First Article Inspections.</li><li>Optimize inspection costs through lean initiatives while maintaining the safety, integrity, and reliability of the product.</li><li>Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.</li><li>Support the development, execution, and approval of validation strategies with the goal of highly capable processes that result in high yield and enable scalability.</li><li>Approve protocols and reports, including data analysis.</li><li>Influence processes towards validation versus manual verification, where possible.</li><li>Support sterilization validation activity, as required.</li><li>Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.</li><li>Provide expertise for NC&#39;s &amp; CAPA&#39;s related to new products, acting as a subject matter expert and mentor in problem-solving and root-causing tools.</li><li>Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies, and tooling &amp; fixture development.</li><li>Support ‘process benchmarking’ by providing quality experience as a process input.</li><li>Promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation.</li><li>Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).</li><li>Ensure Supplier’s Quality Systems can complete process characterization and develop highly capable processes that are scalable.</li><li>Provide Quality input to influence the proper selection of suppliers.</li><li>Support implementation of supplier certification.</li><li>Support Supplier Quality to establish Quality Agreements with sites and suppliers as part of NPI projects.</li><li>Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets.</li><li>Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal &amp; external audits with regulatory representatives.</li><li>Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.</li><li>Support device design into production specifications.</li><li>Lead the efficient and timely transfer of lessons learned knowledge to Quality engineering support and regional peers.</li><li>Provide expert quality process support post-launch per DTAP agreement.</li><li>Support the control of product through appropriate system containment to guard against product escape during pre-released builds.</li></ul><h2>Essential Skills</h2><ul><li>Experience in ISO standards, Design Transfer, Manufacturing, Risk Management, NPI, PFMEA, Validation, Quality engineering, Medical device, Design Control, and Product Transfer.</li><li>Bachelor of Science in Engineering or related subject.</li><li>3-5 years&#39; experience in a quality or technical discipline.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Knowledge of CQA, CTQ, ISO14971, MSA, and PFMEA.</li><li>This role requires the use of judgment in applying professional expertise and working independently with minimal supervision.</li></ul><h2>Work Environment</h2><p>This position is onsite and offers standard benefits, including 2 weeks of PTO and 10 paid holidays. The work environment promotes collaboration and continuous improvement, focusing on maintaining high quality standards in a dynamic setting.</p>

<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 habels @actalentservices.com with 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>As a Quality Engineer specializing in New Product Introduction (NPI), you will advocate and lead design for manufacture and assembly through technical leadership and direction 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, including pFMEA. Your role will involve developing and characterizing processes that are capable, scalable, and produce high yield, as well as supporting the design of robust inspection strategies including CQA&#39;s, CTQ&#39;s, and MSA&#39;s. You will provide quality engineering support for the execution of quality assurance activities during the design transfer phases of new product development.</p><p><br></p><h2>Responsibilities</h2><ul><li>Foster collaborative internal and external professional relationships across Design Divisions, Advanced Operations, and GQO functions associated with design transfer activities.</li><li>Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet NPI project goals.</li><li>Mentor other groups and functions on areas of expertise, particularly focusing on design and process transfer.</li><li>Develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products are free of flaws and function as designed.</li><li>Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates.</li><li>Analyze reports and defective products to determine trends and recommend corrective actions.</li><li>Collaborate with supplier representatives on quality problems, ensure effective corrective actions are implemented, and contribute to supplier quality improvement programs.</li><li>Proficient in risk management practices and tools, with high expertise in failure modes associated with production and production-related processes (PFMEA).</li><li>Support the Risk Management File through risk management principles, evaluating process risks, risk mitigation, and ensuring appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle through robust pFMEA.</li><li>Ensure all Risk Management outputs comply with ISO14971.</li><li>Support the design team to complete CQA/CTQ identification and inputs to dFMEA to enable process risk identification, process characterization, process capability, and robust process control.</li><li>Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies, ensuring inspections are repeatable, efficient, and scalable.</li><li>Lead continuous improvements of inspection methods and sampling plans, focusing on human error risk elimination.</li><li>Lead First Article Inspection (FAI) strategies, both internally and externally, and approve First Article Inspections.</li><li>Optimize inspection costs through lean initiatives while maintaining the safety, integrity, and reliability of the product.</li><li>Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.</li><li>Support the development, execution, and approval of validation strategies with the goal of highly capable processes that result in high yield and enable scalability.</li><li>Approve protocols and reports, including data analysis.</li><li>Influence processes towards validation versus manual verification, where possible.</li><li>Support sterilization validation activity, as required.</li><li>Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.</li><li>Provide expertise for NC&#39;s &amp; CAPA&#39;s related to new products, acting as a subject matter expert and mentor in problem-solving and root-causing tools.</li><li>Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies, and tooling &amp; fixture development.</li><li>Support ‘process benchmarking’ by providing quality experience as a process input.</li><li>Promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation.</li><li>Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).</li><li>Ensure Supplier’s Quality Systems can complete process characterization and develop highly capable processes that are scalable.</li><li>Provide Quality input to influence the proper selection of suppliers.</li><li>Support implementation of supplier certification.</li><li>Support Supplier Quality to establish Quality Agreements with sites and suppliers as part of NPI projects.</li><li>Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets.</li><li>Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal &amp; external audits with regulatory representatives.</li><li>Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.</li><li>Support device design into production specifications.</li><li>Lead the efficient and timely transfer of lessons learned knowledge to Quality engineering support and regional peers.</li><li>Provide expert quality process support post-launch per DTAP agreement.</li><li>Support the control of product through appropriate system containment to guard against product escape during pre-released builds.</li></ul><h2>Essential Skills</h2><ul><li>Experience in ISO standards, Design Transfer, Manufacturing, Risk Management, NPI, PFMEA, Validation, Quality engineering, Medical device, Design Control, and Product Transfer.</li><li>Bachelor of Science in Engineering or related subject.</li><li>3-5 years&#39; experience in a quality or technical discipline.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Knowledge of CQA, CTQ, ISO14971, MSA, and PFMEA.</li><li>This role requires the use of judgment in applying professional expertise and working independently with minimal supervision.</li></ul><h2>Work Environment</h2><p>This position is onsite and offers standard benefits, including 2 weeks of PTO and 10 paid holidays. The work environment promotes collaboration and continuous improvement, focusing on maintaining high quality standards in a dynamic setting.</p>

<h1><strong>Job Title: Quality Engineer </strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a diligent and detail-oriented Quality Engineer  with expertise in Trackwise to ensure compliance with CAPA processes and procedures. The ideal candidate will be responsible for reviewing and approving non-conformance (NC) and corrective and preventive actions (CAPAs) with a focus on completeness, accuracy, effectiveness, and timeliness. This role involves facilitating and guiding teams through all stages of the NC/CAPA process and maintaining rigorous documentation within the eCAPA system. Additionally, the candidate will play a key role in continuous improvement initiatives and engage in cross-site and corporate projects.</p><p><br></p><h2>Responsibilities</h2><ul><li>Ensure compliance with CAPA processes and procedures.</li><li>Review and approve NC and CAPAs, ensuring completeness of actions and records, accuracy, effectiveness, and timeliness.</li><li>Liaise with relevant functional groups and guide teams through all stages of the NC/CAPA process.</li><li>Ensure timely maintenance of a live record with all relevant evidence attached in the eCAPA system.</li><li>Build expertise in facilitating NC and CAPA teams and promote the use of problem-solving techniques (e.g., human error reduction, 4-D, 5 Why&#39;s, fishbone diagrams, process mapping).</li><li>Serve as a highly proficient eCAPA super-user.</li><li>Execute the NC/CAPA review board forums.</li><li>Monitor site NC/CAPA KPIs, including reporting requirements, and provide detailed updates for quality and business review forums.</li><li>Ensure compliance with global requirements and metrics.</li><li>Identify continuous improvement and collaboration opportunities.</li><li>Engage in cross-site and corporate project teams in the NC/CAPA area of expertise.</li><li>Coordinate preparation, participation, and follow-up for internal, corporate, and third-party audit activities.</li></ul><h2>Essential Skills</h2><ul><li>Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).</li><li>Ability to gain knowledge and understanding of U.S. and International medical device regulations.</li><li>Supporting Quality Systems (audits, management review, quality planning, etc.).</li><li>Strong communication and influencing skills.</li><li>Ability to manage multiple tasks simultaneously.</li><li>Strong interpersonal skills.</li><li>Problem-solving skills.</li><li>Analytical thinking skills.</li><li>Ability to work independently.</li><li>Comfort working in a compliance-risk situation.</li><li>Computer literacy, including Microsoft Word, Excel, and PowerPoint.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor&#39;s degree in Engineering, Quality Management, or a related field.</li><li>Minimum of 1-2 years of experience in quality engineering within the medical device industry.</li><li>Proficiency in Trackwise software.</li><li>In-depth understanding of NCR, CAPA processes, and regulatory requirements for medical devices.</li><li>ASQ Certified Quality Engineer (CQE) or equivalent preferred.</li></ul><h2>Work Environment</h2><p>You will enjoy 2 weeks of PTO and 10 paid holidays. The role involves a collaborative work environment where you will interact with various functional groups and participate in cross-site and corporate projects. The work may involve compliance-risk situations, requiring meticulous attention to detail and adherence to regulatory standards. The position also offers opportunities for continuous improvement and professional development.</p>

Quality Engineer I Trackwise)

<h1 style="font-weight: 700;">Job Title: Quality Engineer II</h1><br><h2>Job Description</h2><p>As a Quality Engineer II, you will play a vital role in ensuring the quality performance of products and processes. You will work closely with operations and various business functions, collaborating with cross-functional teams to address quality issues and improve manufacturing processes. Your expertise will drive the approval of NC/CAPA, and proficiency in problem-solving and root-cause analysis.</p><br><h2>Responsibilities</h2><ul><li>Collaborate with operations and business functions to ensure product and process quality.</li><li>Engage with customers, sales, marketing, and field personnel to address top quality issues.</li><li>Approve NC/CAPA and enhance proficiency in problem-solving and root-cause activities.</li><li>Participate in the development and improvement of manufacturing processes for existing products.</li><li>Review change management activities and maintain KPIs for monitoring process and product quality.</li><li>Perform analysis, interpret trends, and take necessary actions based on KPI findings.</li><li>Manage execution and analysis of complaints and product field actions.</li><li>Advocate for Human Factor practices and familiarize with Human Factor science.</li><li>Develop understanding of risk management practices and concepts.</li><li>Optimize inspection methods and sampling, and develop proficiency in statistical methods.</li><li>Engage in internal audits and participate in external audit preparation.</li><li>Assist in the development and review of process and equipment validation/qualification.</li><li>Execute quality activities during manufacturing transfers to other plants/facilities.</li><li>Initiate, contain, and support ship and product holds for potential product escapes.</li></ul><h2>Essential Skills</h2><ul><li>Proven experience in quality engineering and quality assurance.</li><li>Familiarity with supplier, production, and design quality.</li><li>Experience with quality audits and ISO standards.</li><li>Knowledge of US and International Medical Device Regulations.</li><li>Understanding of GDP and GMP practices.</li><li>Proficient in Quality Concepts such as Risk Management, CAPA, Audits, and Statistics.</li><li>Strong communication, project management, and influencing skills.</li><li>Ability to manage multiple tasks simultaneously.</li><li>Capability to represent the Quality function within project teams.</li><li>Strong interpersonal, written, oral communication, and negotiation skills.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Previous industry experience is desired.</li><li>Experience interacting with regulatory agencies like FDA, MoH, TUV is preferred.</li><li>Strong critical thinking and problem-solving skills.</li><li>Ability to work independently and as part of cross-functional teams.</li><li>Computer literacy is essential.</li></ul><h2>Work Environment</h2><p>This position is based onsite in Irvine, CA. The role offers a comprehensive benefits package including 2 weeks of PTO and 10 paid holidays.</p><br>

Quality Engineer II

<h1><strong>Job Title: Quality Engineer Manager </strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a skilled Quality Engineer with proven leadership capabilities to oversee and enhance our quality assurance systems. The ideal candidate will be responsible for ensuring compliance with medical device regulations, improving manufacturing processes, and driving continuous quality improvements within our dynamic and growing company.</p><p><br></p><h2>Responsibilities</h2><ul><li>Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure product quality and compliance.</li><li>Lead and mentor the quality assurance team, including quality engineers and quality control technicians.</li><li>Ensure all products and processes comply with relevant medical device regulations and standards, including ISO and FDA 21 CFR Part 11 and Part 820 requirements.</li><li>Prepare and manage documentation in support of regulatory submissions, audits, and inspections.</li><li>Oversee the monitoring of injection molding processes to ensure consistent product quality.</li><li>Identify and implement process improvements to enhance product quality, reduce waste, and improve manufacturing efficiency.</li><li>Analyze data on product quality and process performance to identify trends and areas for improvement.</li><li>Prepare and present reports on quality metrics and performance to <span style="color: rgb(8, 7, 7); background-color: none;">senior</span> personnel.</li><li>Lead root cause analysis and corrective action activities for non-conforming products.</li><li>Collaborate with cross-functional teams, including production, engineering, and R&amp;D, to implement effective corrective and preventive actions.</li><li>Manage supplier quality performance, including conducting supplier audits and assessments.</li><li>Work with suppliers to resolve quality issues and ensure the supply of high-quality materials.</li><li>Serve as the primary point of contact for customer quality concerns and complaints.</li><li>Support customer audits and visits by providing necessary documentation and information.</li><li>Drive continuous improvement initiatives aimed at enhancing product quality, reducing costs, and improving efficiency.</li><li>Lead and participate in cross-functional quality improvement teams.</li><li>Develop and conduct training programs for quality assurance personnel and promote a culture of quality awareness and continuous improvement within the organization.</li><li>Conduct internal audits to ensure compliance with quality management systems and regulatory requirements.</li><li>Prepare for and support external audits by regulatory bodies and customers.</li></ul><h2>Essential Skills</h2><ul><li>Minimum of 7-10 years of experience in a quality role within the medical device manufacturing industry.</li><li>Extensive experience in plastic injection molding.</li><li>Previous management experience required.</li><li>5+ years experience with FDA 21 CFR Part 11 and Part 820.</li><li>5+ years experience with ISO 9001.</li><li>Strong leadership and team management skills.</li><li>Excellent analytical and problem-solving skills.</li><li>Proficiency in statistical analysis and quality management software.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor’s degree in engineering, preferably in Mechanical, Industrial, or Plastics Engineering. A master’s degree is a plus.</li><li>Certifications such as Certified Quality Manager (CQM), Certified Quality Engineer (CQE), and/or Certified Quality Auditor (CQA) from ASQ are highly desirable.</li><li>In-depth understanding of quality assurance principles and methodologies.</li><li>Extensive knowledge of injection molding processes and equipment.</li><li>Familiarity with medical device regulations and standards.</li><li>Practical experience and knowledge of metrology and GD&amp;T techniques.</li><li>Effective communication and interpersonal skills.</li></ul><h2>Work Environment</h2><p>This role is set in a fast-paced, deadline-driven manufacturing floor and office environment, requiring strong attention to detail and adaptability to shifting priorities.</p>

Quality Engineer Manager

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>We are seeking a skilled Quality Engineer with proven leadership capabilities to oversee and enhance our quality assurance systems. The ideal candidate will be responsible for ensuring compliance with medical device regulations, improving manufacturing processes, and driving continuous quality improvements within our dynamic and growing company.</p><br><h2>Responsibilities</h2><ul><li>Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure product quality and compliance.</li><li>Lead and mentor the quality assurance team, including quality engineers and quality control technicians.</li><li>Ensure all products and processes comply with relevant medical device regulations and standards, including ISO and FDA 21 CFR Part 11 and Part 820 requirements.</li><li>Prepare and manage documentation in support of regulatory submissions, audits, and inspections.</li><li>Oversee the monitoring of injection molding processes to ensure consistent product quality.</li><li>Identify and implement process improvements to enhance product quality, reduce waste, and improve manufacturing efficiency.</li><li>Analyze data on product quality and process performance to identify trends and areas for improvement.</li><li>Prepare and present reports on quality metrics and performance to <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">senior</span></span> personnel.</li><li>Lead root cause analysis and corrective action activities for non-conforming products.</li><li>Collaborate with cross-functional teams, including production, engineering, and R&amp;D, to implement effective corrective and preventive actions.</li><li>Manage supplier quality performance, including conducting supplier audits and assessments.</li><li>Work with suppliers to resolve quality issues and ensure the supply of high-quality materials.</li><li>Serve as the primary point of contact for customer quality concerns and complaints.</li><li>Support customer audits and visits by providing necessary documentation and information.</li><li>Drive continuous improvement initiatives aimed at enhancing product quality, reducing costs, and improving efficiency.</li><li>Lead and participate in cross-functional quality improvement teams.</li><li>Develop and conduct training programs for quality assurance personnel and promote a culture of quality awareness and continuous improvement within the organization.</li><li>Conduct internal audits to ensure compliance with quality management systems and regulatory requirements.</li><li>Prepare for and support external audits by regulatory bodies and customers.</li></ul><h2>Essential Skills</h2><ul><li>Minimum of 7-10 years of experience in a quality role within the medical device manufacturing industry.</li><li>Extensive experience in plastic injection molding.</li><li>Previous management experience required.</li><li>5+ years experience with FDA 21 CFR Part 11 and Part 820.</li><li>5+ years experience with ISO 9001.</li><li>Strong leadership and team management skills.</li><li>Excellent analytical and problem-solving skills.</li><li>Proficiency in statistical analysis and quality management software.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor’s degree in engineering, preferably in Mechanical, Industrial, or Plastics Engineering. A master’s degree is a plus.</li><li>Certifications such as Certified Quality Manager (CQM), Certified Quality Engineer (CQE), and/or Certified Quality Auditor (CQA) from ASQ are highly desirable.</li><li>In-depth understanding of quality assurance principles and methodologies.</li><li>Extensive knowledge of injection molding processes and equipment.</li><li>Familiarity with medical device regulations and standards.</li><li>Practical experience and knowledge of metrology and GD&amp;T techniques.</li><li>Effective communication and interpersonal skills.</li></ul><h2>Work Environment</h2><p>This role is set in a fast-paced, deadline-driven manufacturing floor and office environment, requiring strong attention to detail and adaptability to shifting priorities.</p><br>

<h1><strong>Job Description: Quality Engineer</strong></h1><p>We are seeking a dedicated Quality Engineer who is committed to adhering to safety regulations and contributing to a safe work environment. The ideal candidate will possess a keen attention to detail, ensuring that quality standards are consistently met. They should be proficient in analytical and problem-solving skills, with the ability to identify issues and develop proactive solutions that enhance efficiency. Familiarity with data analysis and visualization tools such as Power BI, Tableau, Excel, SQL, and Python is crucial, along with strong organizational skills to manage multiple tasks efficiently.</p><p><br></p><h2>Responsibilities</h2><ul><li>Analyze data using statistical tools to identify trends and generate actionable insights for quality and efficiency improvements.</li><li>Lead and coordinate corrective and preventive actions in response to customer complaints and non-conformances, managing the investigation and resolution process from start to finish.</li><li>Utilize expertise in root cause analysis (RCA) to identify underlying issues, applying 8D methodology to structure problem-solving processes and develop effective solutions that prevent recurrence.</li><li>Oversee the non-conformance process by identifying, documenting, and tracking quality issues, collaborating closely with production teams to address deviations from product specifications.</li><li>Support the development, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with ISO 9001 and AS 9100 standards, leading internal audits and ensuring compliance with relevant industry standards and regulations.</li><li>Collaborate with engineering and production teams to identify and implement process improvements, leveraging Lean and Six Sigma principles to reduce waste, improve quality, and streamline production processes.</li><li>Provide guidance and training to production teams on quality standards, inspection procedures, and best practices, promoting a culture of continuous improvement.</li><li>Perform other duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Strong understanding of Quality Management Systems (QMS) and familiarity with ISO 9001 and AS 9100 standards.</li><li>Experience in root cause analysis and problem-solving methodologies such as 8D or FMEA.</li><li>Excellent communication and interpersonal skills for effective collaboration with internal teams, external suppliers, and customers.</li><li>Ability to produce clear, concise documentation and reports.</li><li>Bachelor&#39;s Degree in Quality Assurance, Engineering, Manufacturing, or a related field.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Knowledge of Six Sigma principles and methodologies.</li><li>Experience with PPAP, internal and external audits.</li><li>Expertise in quality control, management, and assurance in automotive and aerospace industries.</li></ul>

Quality Engineering

<h1><strong>Job Title: Quality Engineering Technician</strong></h1><p><br></p><h2>Job Description</h2><p>This role requires a dedicated and proactive individual to join the engineering team as a Quality Engineering Technician on the 3rd shift. </p><p>The technician will serve as the main liaison between the Quality Engineers and the Machinists, ensuring the smooth operation and quality of products. </p><p>This technical position demands strong problem-solving abilities, as it involves conducting capability studies, identifying non-conformances, and implementing corrective actions.</p><p><br></p><h2>Responsibilities</h2><ul><li>Conduct capability studies to assess production processes.</li><li>Identify non-conformances and develop corrective actions to ensure product specifications are met.</li><li>Read and interpret PFMEAs, inspection plans, work instructions, and control plans.</li><li>Perform tasks in strict compliance with manufacturing standards (SOPs) and regulatory requirements (i.e., GMPs).</li><li>Collaborate on calibration processes.</li><li>Demonstrate ownership and accountability to the production schedule, ensuring product quality.</li><li>Maintain documentation for auditing purposes.</li><li>Check and update quality control policies.</li><li>Monitor different stages of production to prevent product defects.</li></ul><h2>Essential Skills</h2><ul><li>Experience conducting capability studies.</li><li>Ability to identify non-conformances.</li><li>Proficiency in quality documentation, including reading work instructions, inspection plans, and PFMEAs.</li><li>Proven problem-solving skills.</li><li>Calibration experience.</li><li>Associates degree in Engineering or Quality certification.</li></ul><h2>Work Environment</h2><p>The position is onsite, requiring a 40-hour work week on the 3rd shift. </p><p>The technician will collaborate with all departments, primarily serving as the liaison between engineering and machinists. </p><p>The role involves spending significant time on the production floor, with approximately 30% dedicated to documentation tasks. </p><p>Training will initially occur on the 1st shift. The work environment offers autonomy in managing workloads and opportunities for internal promotion. </p><p>Employees receive 10 days of PTO, 6 paid holidays, and access to Udemy after 6 months.</p>

Quality Engineering Technician

<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>

<h1><strong>Quality Coordinator </strong></h1><h2>Job Description</h2><p>We are seeking a dedicated Quality Coordinator to support the inventory, setup, and documentation of new equipment acquired. The role involves supporting O2 and CO2 cylinder change outs in both GMP and Non-GMP labs, conducting walkdowns, and performing gauge and equipment checks with required documentation. The Quality Coordinator will also handle manual documentation, technical documentation, and quality checks, as well as oversee on-site contractors and help track timelines.</p><p><br></p><h2>Responsibilities</h2><ul><li>Support inventory, setup, and documentation of new equipment</li><li>Assist with O2 and CO2 cylinder change outs in GMP &amp; Non-GMP labs, ensuring proper documentation in GMP logbooks</li><li>Conduct walkdowns and gauge and equipment checks with necessary documentation</li><li>Perform manual documentation, technical documentation, and quality checks</li><li>Oversee and check on-site contractors and help track timelines</li><li>Support cleaning and upkeep functions in main areas</li></ul><h2>Essential Skills</h2><ul><li>Quality check</li><li>Visual inspection</li><li>Documentation review</li><li>Quality assurance</li><li>Inspection</li><li>Facility management</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>HS Diploma (Associates or Bachelors preferred)</li><li>Prior experience in quality coordination</li><li>Experience with documentation, SOP review, and GMP protocols</li><li>Mechanically inclined</li></ul><p><br></p>

Quality Facility Coordinator

<h1 style="font-weight: 700;">Job Title: Quality Inspector</h1><br><h2>Job Description</h2><p>The Quality Inspector is responsible for verifying and approving production runs, completing associated paperwork, performing regular quality checks on products across various production machines, and ensuring products meet specifications for release. The role requires following all safety rules and company-established manufacturing and quality methods while meeting Key Performance Indicators (KPIs). This involves reading computer specifications, verifying lot numbers, quarantining products, and conducting root cause analysis. The Quality Inspector will conduct quality checks on the floor every 60 minutes.</p><br><h2>Responsibilities</h2><ul><li>Verify and approve production runs.</li><li>Complete and maintain accurate paperwork.</li><li>Perform regular quality checks on products across various production machines.</li><li>Ensure products meet specifications and are ready for sale.</li><li>Follow all safety rules and company-established manufacturing and quality methods.</li><li>Meet Key Performance Indicators (KPIs).</li><li>Read and interpret specifications from a computer.</li><li>Verify lot numbers and quarantine products if necessary.</li><li>Conduct root cause analysis.</li><li>Perform 60-minute quality checks on the floor.</li></ul><h2>Essential Skills</h2><ul><li>1+ years of experience in Quality Control or Inspection.</li><li>Experience with FDA and/or GMP is preferred, but open to quality experience outside of these industries.</li><li>Proficiency in quality control, quality checks, inspection, and documentation.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Ability to work in both floor and office environments.</li><li>Willingness to work the specified shifts and adapt to overtime opportunities.</li></ul><h2>Work Environment</h2><p>This position involves working both on the production floor to check products and in an office setting for documentation. The work environment is climate-controlled. The position will begin with 2-3 weeks of training on the 1st shift (Monday to Friday, 6:00 am – 2:30 pm) and then transition to the 3rd shift (Sunday to Thursday, 10:00 pm – 6:30 am). The opportunity for overtime is available every other Saturday, but it is not mandatory. The company culture is inclusive and diverse, with flags representing all the different countries of employees. There is significant growth potential, as demonstrated by the quality supervisor who began as a quality inspector. Employees are eligible for a retention bonus of $500 after 3 months and another $500 after 6 months.</p><br>

Quality Inspector

<h1 style="font-weight: 700;">Job Title: Quality Inspector</h1><br><h2>Job Description</h2><p>We are seeking a detail-oriented Quality Inspector to join our team in a medical device manufacturing setting. You will be responsible for ensuring product quality through careful inspection and documentation, adhering to industry standards.</p><br><h2>Responsibilities</h2><ul><li>Interpret specifications and blueprints to understand dimensional, physical, functional, and visual requirements.</li><li>Inspect products for various quality issues and document findings per ISO and FDA requirements within the ERP system.</li><li>Perform part inspection and measure dimensions of incoming, in-process, first piece, and finished workpieces.</li><li>Utilize various precision measuring instruments, including optical comparators, CMM or vision machines, along with templates and fixtures.</li><li>Assist with CAPA, NCR, and non-conformance processes by collecting data and entering it into spreadsheets and databases.</li><li>Support the disposition of nonconforming products through RMA procedures for both internal and customer returns.</li></ul><h2>Essential Skills</h2><ul><li>3 years of quality inspection experience.</li><li>Experience working with ISO standards.</li><li>Proficiency in using micrometers and calipers.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience with CAPA and NCR processes.</li><li>Familiarity with ISO 13485 standards.</li></ul><h2>Work Environment</h2><p>You will be working within a medical device manufacturing and office setting. Training will be provided on your designated shift. Available shifts include 1st shift (6:00 am – 2:30 pm, Monday through Friday) and 2nd shift (2:30 pm – 1:00 am).</p><br>

<h1 style="font-weight: 700;">Job Title: Quality Investigator</h1><br><h2>Job Description</h2><p>Lead and manage complex investigations related to deviations, non-conformances, and quality events across manufacturing, packaging, and laboratory operations. Perform thorough root cause analyses and collaborate cross-functionally to gather data and ensure accurate, complete, and timely investigation reports.</p><br><h2>Responsibilities</h2><ul><li>Drive the closure of investigations and deviations in accordance with internal procedures and regulatory expectations.</li><li>Facilitate and lead cross-functional team meetings focused on deviation management and investigation progress.</li><li>Author and review investigation reports, CAPAs, and trend analyses to ensure clarity, scientific soundness, and regulatory readiness.</li><li>Monitor and track investigation metrics to identify systemic issues and recommend process improvements.</li><li>Support regulatory inspections and internal audits by presenting investigation documentation and participating in discussions with auditors.</li><li>Mentor junior investigators and provide training on investigation techniques and quality system requirements.</li></ul><h2>Essential Skills</h2><ul><li>Quality assurance</li><li>Investigator</li><li>Root cause analysis</li><li>CAPA</li><li>Deviation management</li><li>Investigation</li><li>Compliance</li><li>Document control</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field.</li><li>Minimum 8–10 years of experience in a GMP-regulated pharmaceutical or biotechnology environment, with at least 5–7 years focused on deviation management and investigations.</li><li>Strong knowledge of cGMP, ICH Q10, FDA, EMA, and other global regulatory requirements.</li><li>Demonstrated expertise in root cause analysis and CAPA development.</li><li>Proficiency in quality systems software (e.g., TrackWise) is preferred.</li></ul><h2>Work Environment</h2><p>The role requires working Monday through Friday, 100% onsite in Billerica, MA. You will be part of the tech operations team supporting quality.</p><br>

Quality Investigator

<p><br></p><h2>Job Description</h2><p>Lead and manage complex investigations related to deviations, non-conformances, and quality events across manufacturing, packaging, and laboratory operations. Perform thorough root cause analyses and collaborate cross-functionally with Technical Operations, Manufacturing, Quality Control, and Regulatory Affairs to gather data and ensure accurate, complete, and timely investigation reports. Drive the closure of investigations and deviations in accordance with internal procedures and regulatory expectations. Facilitate and lead cross-functional team meetings focused on deviation management and investigation progress.</p><p><br></p><h2>Responsibilities</h2><ul><li>Author and review investigation reports, CAPAs, and trend analyses to ensure clarity, scientific soundness, and regulatory readiness.</li><li>Monitor and track investigation metrics to identify systemic issues and recommend process improvements.</li><li>Support regulatory inspections and internal audits by presenting investigation documentation and participating in discussions with auditors.</li><li>Mentor junior investigators and provide training on investigation techniques and quality system requirements.</li></ul><h2>Essential Skills</h2><ul><li>Expertise in quality assurance and deviation management.</li><li>Proficiency in root cause analysis and CAPA development.</li><li>Strong knowledge of cGMP, ICH Q10, FDA, EMA, and other global regulatory requirements.</li><li>Minimum 8–10 years of experience in a GMP-regulated pharmaceutical or biotechnology environment, with at least 5–7 years focused on deviation management and investigations.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field.</li><li>Proficiency in quality systems software, such as TrackWise, is preferred.</li></ul><h2>Work Environment</h2><p>The role requires working Monday through Friday, 100% onsite in Framingham, MA. </p>

<h1 style="font-weight: 700;">Job Title: Quality Lab Technician</h1><br><h2>Job Description</h2><p>We are seeking a dedicated Quality Lab Technician to join our team, working within a dynamic lab setting to ensure the highest standards of quality control and assurance.</p><br><h2>Responsibilities</h2><ul><li>Check in process and finished products to ensure compliance with quality standards.</li><li>Conduct strength and tensile testing using the appropriate measuring tools.</li><li>Prepare samples, load them into a Gas Chromatography (GC) system, and log the results accurately.</li><li>Review products for adherence to color standards.</li><li>Test the seal strength of products to ensure durability.</li><li>Document and report the results of lab tests systematically.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in quality control and quality assurance processes.</li><li>Experience in laboratory settings, including familiarity with lab testing procedures.</li><li>Associates degree or high school diploma with relevant quality or laboratory experience.</li><li>Ability to work efficiently in fast-paced environments such as production, manufacturing, or food service.</li><li>Understanding of chemistry and experience with Gas Chromatography.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Good organizational skills and attention to detail.</li></ul><h2>Work Environment</h2><p>This position operates on a 1st shift schedule from 7am-3pm, with potential openings for 2nd or 3rd shifts. Initial training will be conducted during the 1st shift for the first four weeks. The work environment is a collaborative lab setting, requiring teamwork and interaction with films, foils, chemicals, and peelable solutions.</p><br>

Quality Lab Technician

<h1 style="font-weight: 700;">Job Title: Quality Lab Technician</h1><br><h2>Job Description</h2><p>The Quality Lab Technician plays a crucial role in maintaining and ensuring the quality of samples and materials within the laboratory setting. This position offers the opportunity to work in a dynamic environment with state-of-the-art equipment, contributing to the growth of a leading cosmetic manufacturer.</p><br><h2>Responsibilities</h2><ul><li>Assist in sample processing in accordance with Standard Operating Procedures (SOPs).</li><li>Issue and apply release stickers on approved raw materials and bulk products.</li><li>Calibrate and maintain lab equipment and perform routine equipment maintenance.</li><li>Maintain inventory and ensure proper levels of department supplies.</li><li>Order, unpack, log, and store supplies.</li><li>Document laboratory information accurately and completely in a timely manner.</li><li>Log, label, and process specimens and paperwork for testing.</li><li>Perform housekeeping and preventive maintenance of laboratory instruments.</li><li>Ensure the laboratory area is neat, clean, and organized.</li><li>Maintain an awareness of cGMP, Good Laboratory Practices (GLP), good housekeeping, and safety in the laboratory.</li><li>Other duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in sample processing, pH meter usage, and viscometer operation.</li><li>Knowledge of GMP compliance and good laboratory practices.</li><li>Strong understanding of Microsoft Office, including Word, Excel, and Outlook.</li><li>Excellent written and verbal communication skills.</li><li>Ability to prioritize, multitask, and manage time effectively.</li><li>Attention to detail and reliability.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>BA or BS Degree in Biological Science or Chemistry, or a combination of education and related experience.</li><li>High School Graduate or GED is required.</li><li>Experience in a laboratory or work in the cosmetology industry is preferred.</li><li>Ability to work cooperatively with team members and supervisors.</li><li>Understanding of verbal and written directions.</li></ul><h2>Work Environment</h2><p>The position requires working in both lab and production environments. Shift starts between 10:00 am and 12:00 pm, providing flexibility in work hours. The facility is equipped with state-of-the-art technology, offering a modern and innovative work setting.</p><br>

<h1 style="font-weight: 700;">Job Title: Quality Lab Technician</h1><br><h2>Job Description</h2><p>We are seeking a dedicated Quality Lab Technician to join our team. The successful candidate will work within a lab setting, ensuring the quality and integrity of our products through rigorous testing and analysis.</p><br><h2>Responsibilities</h2><ul><li>Check in process and finished products to ensure quality standards are met.</li><li>Conduct strength and tensile testing to verify product durability.</li><li>Measure product dimensions down to 1/64th of an inch using precision tools.</li><li>Prepare samples for Gas Chromatography (GC) testing, load them into GC, and accurately log results.</li><li>Review products for color standards compliance.</li><li>Test seal strength to ensure product safety.</li><li>Document results of lab tests meticulously to maintain accurate records.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in quality control and quality assurance within a laboratory setting.</li><li>An Associate&#39;s degree or a high school diploma with relevant quality or laboratory experience.</li><li>Experience with quality control or lab testing, preferably within the industry.</li><li>Ability to thrive in a fast-paced environment such as production, manufacturing, or food service.</li><li>Strong understanding of Chemistry and Gas Chromatography (GC).</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in a fast-paced environment including production, manufacturing, or food service.</li><li>Excellent organizational skills and attention to detail.</li></ul><h2>Work Environment</h2><p>The position operates on the 1st shift from 7am to 3pm. Initially, training will occur on the 1st shift for the first four weeks. The role requires working both in the lab and occasionally on the production floor to gather samples. Shift options may change, offering flexibility to transition to 2nd or 3rd shifts based on preferences. The work environment is lab-based, team-oriented, and involves collaboration with coworkers in the lab and production personnel. The technician will engage with films, foils, chemicals, and peelable solutions, ensuring a dynamic and interactive work atmosphere.</p><br>

<h1><strong>Quality Lab Technician</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking dedicated Lab Technicians to join our team in performing essential quality seed testing at one of the largest cotton seed sites globally. As a Quality Lab Technician, you will play a pivotal role in analyzing incoming raw materials and finished products to ensure top-quality seeds are provided to cotton farmers across the United States and Mexico.</p><p><br></p><h2>Responsibilities</h2><ul><li>Perform visual quality inspection on seed samples.</li><li>Conduct basic laboratory tests including pH, protein assays, moisture testing, and titrations.</li><li>Execute warm and cool germination testing.</li><li>Carry out purity analysis of seeds.</li><li>Perform seed counts accurately.</li><li>Organize and conduct sampling procedures for products.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in quality control and quality assurance practices.</li><li>Experience with visual inspections and quality inspections.</li><li>Knowledge in wet chemistry and QC processes.</li><li>Familiarity with farm work and agriculture.</li><li>Understanding of biology, chemistry, production, protein analysis, and germination.</li><li>Ability to conduct pH testing and work within manufacturing quality standards.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>High School Diploma required.</li><li>Bachelor of Science in Agriculture, Natural Science, Plant Science, or Crop Science preferred.</li><li>Must possess a Passport or Birth Certificate for onboarding.</li></ul><h2>Work Environment</h2><p><strong>The work environment includes standard operating hours from Monday to Friday, 7:00 am to 5:30 pm. During harvest season, from November through January, two shifts are available: 7:00 am to 5:30 pm and 5:00 pm to 3:30 am, from Sunday to Saturday. From February to May, weekend work may be required. Candidates must be open to working any day of the week and able to work either the first or second shift, with potential for up to 50 hours per week during peak seasons.</strong></p>

<h1><strong>Job Title: Quality Lab Technician</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a dedicated Quality Lab Technician to join our team, working within a dynamic lab setting to ensure the highest standards of quality control and assurance.</p><p><br></p><h2>Responsibilities</h2><ul><li>Check in process and finished products to ensure compliance with quality standards.</li><li>Conduct strength and tensile testing using the appropriate measuring tools.</li><li>Prepare samples, load them into a Gas Chromatography (GC) system, and log the results accurately.</li><li>Review products for adherence to color standards.</li><li>Test the seal strength of products to ensure durability.</li><li>Document and report the results of lab tests systematically.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>High School Diploma with Quality or Lab Experience (1+ Years)</li><li>Scientific Associates Degree (Entry Level)</li></ul>

<p><strong>Description</strong></p>
					<p>Guiding quality issues during 3rd shift
Will be working with operations, packaging team and mixing team- overseeing quality
Need to be able to help quality techs with lab testing when needed
Project work- help with process improvements like SOP writing and etc

Oversee 2 quality technicians that do the following tasks:
Follow GMP protocols
Work closely with production and maintenance teams to ensure quality standards
Execute laboratory tests on materials and products, safeguarding compliance.
Support food safety and regulatory programs, including Gluten-Free and Organic initiatives.
Perform regular inspections to identify non-conformances and improvement opportunities.
Verify and manage product label precision and compliance.
Monitor sanitation chemicals, ensuring they meet safety thresholds.
Calibrate lab equipment to maintain quality consistency.
Conduct inline process checks and adjustments to maintain standards.
Conduct swab tests to ensure sanitation efficacy.
Ensure ingredients meet high standards.

Need to be able to step into any of the above tasks as well.</p>
					<p><strong>Skills</strong></p>
					<p>Quality assurance, Gmp, food safety, lead, Quality control, Haccp, Supervision, PCQI, SQF</p>
					<p><strong>Top Skills Details</strong></p>
					<p>Quality assurance,Gmp,food safety,lead</p>
					<p><strong>Additional Skills &amp; Qualifications</strong></p>
					<p>B.S. degree in Life Sciences with 2 years of GMP experience in a food, pharmaceutical or biotech industry
or 
Associates degree in Life Sciences with 4+ years of GMP experience in a food, pharmaceutical or biotech industry
or 
high school diploma with 6+ years of GMP experience in a food, pharmaceutical or biotech industry

2+ years of quality experience
Any SOP writing experience is a plus
HACCP certified- plus
PCQI and SQF experience- plus
Spanish speaking- plus as majority of workforce is Spanish speaking</p>
					<p><strong>Experience Level</strong></p>
					<p>Intermediate Level</p>

Quality Lead

<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>

<h1><strong>Job Description: Quality Manager</strong></h1><p>This role involves leading and developing a team of quality professionals at a high-impact electric vehicle seating manufacturing site. The position offers direct visibility to site leadership and OEM customers, making it a critical leadership role.</p><p><br></p><h2>Responsibilities</h2><ul><li>Lead 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>Bachelor’s degree required; Master’s preferred.</li><li>Must pass a color vision assessment.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in seating systems and/or EV manufacturing strongly preferred.</li><li>Experience at companies such as Rivian, Lear, Etienne, Tesla, Ford, or other companies working on electric vehicles (EVs).</li><li>Experience in customer relations, regulatory compliance, and data analysis.</li></ul>

Quality Manager

<h1><strong>Job Description: Quality Manager</strong></h1><p><br></p><p>***This role is 100% onsite and can sit out of Champaign, Illinois or Mesa, Arizona. </p><p><br></p><p>This role involves leading and developing a team of quality professionals at a high-impact electric vehicle seating manufacturing site. The position offers direct visibility to site leadership and OEM customers, making it a critical leadership role.</p><p><br></p><h2>Responsibilities</h2><ul><li>Lead 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>Bachelor’s degree required; Master’s preferred.</li><li>Must pass a color vision assessment.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in seating systems and/or EV manufacturing strongly preferred.</li><li>Experience at companies such as Rivian, Lear, Etienne, Tesla, Ford, or other companies working on electric vehicles (EVs).</li><li>Experience in customer relations, regulatory compliance, and data analysis.</li></ul>

<h1 style="font-weight: 700;">Job Title: Quality Manager</h1><br><h2>Job Description</h2><p>Responsible for the efficient and effective operation of the quality systems for manufacturing and repair functions. You will develop and implement processes and procedures to ensure that products and services consistently meet quality standards and comply with domestic and global regulatory standards.</p><br><h2>Responsibilities</h2><ul><li>Develop and implement quality systems and procedures.</li><li>Ensure compliance with domestic and global regulatory standards.</li><li>Oversee quality management operations to meet product and service quality standards.</li><li>Collaborate with the team to improve quality processes.</li><li>Manage and guide a team of six direct reports.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor’s degree in a related field.</li><li>Minimum 5 years of experience in quality management.</li><li>Minimum 10 years of experience working in a quality role in the aviation industry.</li><li>Working knowledge of quality systems related to FAA and AS9100 standards.</li><li>Proficiency in Microsoft Office.</li><li>Strong problem-solving, critical thinking, and prioritizing skills.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience with ODA authorization.</li><li>Experience with obtaining or maintaining Supplemental Type Certificates (STC) or Product Manufacturer Approval (PMA) programs.</li><li>Excellent verbal, written, and interpersonal communication skills.</li></ul><h2>Work Environment</h2><p>The work schedule is Monday through Friday, from 8 AM to 5 PM. The position involves leading a team of six direct reports. The company offers a growing environment with a great work-life balance.</p><br>

<h1><strong>Job Title: Quality Manager</strong></h1><p><br></p><h2>Job Description</h2><p>This position requires strong leadership skills to motivate and guide production teams. Chemistry <span style="color: rgb(8, 7, 7); background-color: none;">background</span> and strategic thinking are essential to enhance production processes, reduce costs, and meet quality standards. The Quality Manager is a key figure in maintaining pharmaceutical manufacturing operations at the highest standards of quality and efficiency.</p><p><br></p><h2>Responsibilities</h2><ul><li>Manage production schedules according to staffing guidelines and ensure production goals are met.</li><li>Monitor and track production metrics including Variance, Yields, Days Lost, and Product/Labor ratio.</li><li>Review and modify controlled documents including SOPs, variances, batch production, control records, OOT/OOS, QC alerts and notices, corrective action requests, and investigative reports as needed.</li><li>Ensure batch documentation is accurate and completed in a timely manner.</li><li>Ensure personnel perform competently and in compliance with company policies, SOPs, and cGMPs.</li><li>Ensure adherence to safety protocols.</li><li>Conduct performance evaluations and disciplinary actions as needed.</li><li>Maintain positive employee relationships across all business units.</li><li>Participate in internal and external audits by government agencies, customers, and internal Quality Assurance personnel.</li><li>Work with internal and external entities to complete repairs and improvements on plant facilities, systems, machines, and equipment.</li><li>Coordinate with outside contractors and follow up on contracts as needed.</li><li>May be required to carry an electronic device for 24-hour call in.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in efficient manufacturing techniques, process improvement, and production scheduling.</li><li>Strong skills in material and supply chain management.</li><li>Problem-solving skills and an analytical thought process.</li><li>Business writing skills including the ability to write investigative reports and summaries.</li><li>Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and government regulations.</li><li>Attention to detail and ability to coordinate various activities simultaneously.</li><li>Ability to manage multiple priorities and work with minimal supervision.</li><li>Ability to communicate courteously and professionally with co-workers, management team members, and other individuals.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>5+ years of work experience in the Science/Pharma/Manufacturing/QA field.</li><li>At least 3-5 years of management experience.</li><li>Proven experience in quality assurance, quality control, and quality management.</li></ul><h2>Work Environment</h2><p>The role operates in a dynamic pharmaceutical manufacturing environment that requires adherence to safety protocols and standards. The position may require carrying an electronic device for 24-hour call in. The work involves collaboration with internal and external entities, including contractors, to ensure efficient operations and facility improvements.</p>

<h1><strong>Job Title: Quality Specialist</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a dedicated and detail-oriented Quality Specialist to join our team. This role involves performing various laboratory analyses, ensuring adherence to safety standards, and maintaining rigorous documentation practices. The ideal candidate will have experience in quality control and assurance, along with excellent analytical skills.</p><p><br></p><h2>Responsibilities</h2><ul><li>Perform analysis in the laboratory with minimal supervision, ensuring adherence to established standards, mobile phases, and reagents.</li><li>Calibrate and monitor laboratory equipment such as HPLC, GC, ICP, etc.</li><li>Analyze raw materials, intermediates, stability samples, and finished products using various analytical and instrumental methods.</li><li>Perform calculations, collect, and prepare data for evaluation.</li><li>Keep the supervisor informed of work status.</li><li>Investigate out-of-specification (OOS) results under the guidance of staff.</li><li>Maintain good documentation practices.</li><li>Display and promote positive safety behaviors at all times.</li><li>Use proper personal protective equipment and appropriate safety tools to ensure oneself and others&#39; safety.</li><li>Ensure the area and equipment operate at the highest safety levels.</li><li>Please make sure all personnel in the area follow with safety directives and maintain a neat and clean workspace.</li></ul><h2>Essential Skills</h2><ul><li>Quality assurance</li><li>Quality control</li><li>GMP</li><li>Audit</li><li>Document control</li><li>Food safety</li><li>FDA</li><li>HACCP</li><li>Biology</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Associate degree in a relevant scientific discipline (chemistry, biology, science, etc.); Bachelor&#39;s degree preferred.</li><li>Broad general knowledge of quality control techniques and methods.</li><li>Broad understanding of safety, laboratory hygiene, and GMP rules.</li><li>0-3 years of lab experience.</li><li>Experience with Microsoft Office (Outlook, Word, and Excel).</li></ul><h2>Work Environment</h2><p>The Quality Specialist will work in a laboratory setting, utilizing various analytical and instrumental methods. The role requires adherence to rigorous safety standards and the use of personal protective equipment. The work environment emphasizes cleanliness, organization, and compliance with safety directives to ensure a safe and efficient workplace for all employees.</p>

Quality Specialist

<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><li>Collaborate with cross-functional teams to streamline QMS documentation and improve quality procedures.</li><li>Provide training and mentorship on quality standards and best practices across departments.</li><li>Interface with customers and suppliers to resolve quality concerns and ensure compliance with specifications.</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>

Quality Systems Engineer

<h1 style="font-weight: 700;">Job Title: Quality Systems Engineer</h1><br><h2>Job Description</h2><p>The Quality Systems Engineer is responsible for developing, implementing, and maintaining quality systems in compliance with IATF and ISO 9001 standards. This role ensures that internal processes, documentation, and audits align with customer and regulatory requirements, supporting continuous improvement and operational excellence.</p><br><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><li>Collaborate with cross-functional teams to streamline QMS documentation and improve quality procedures.</li><li>Provide training and mentorship on quality standards and best practices across departments.</li><li>Interface with customers and suppliers to resolve quality concerns and ensure compliance with specifications.</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, preferably in automotive or metal stamping environments.</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><h2>Additional Skills &amp; Qualifications</h2><ul><li>Excellent organizational, analytical, and communication skills.</li></ul><h2>Work Environment</h2><p>This role operates within a metal stamping/manufacturing environment, accommodating 80 - 100 employees across 2 shifts.</p><br>

<h1 style="font-weight: 700;">Job Title: Quality Technician</h1><br><h2>Job Description</h2><p>In this role, you will support our Quality Manager in ensuring the highest standards of quality within our cylinder manufacturing processes. You will have the opportunity to work in a dynamic environment where your skills will help ensure that our production meets specified standards of dimensional accuracy, surface finish, and material integrity.</p><br><h2>Responsibilities</h2><ul><li>Monitor production processes to ensure dimensional accuracy, surface finish, and material integrity meet specified standards.</li><li>Conduct inspections and analyze defects in manufacturing processes.</li><li>Collaborate with engineering and production teams to implement corrective actions.</li><li>Participate in continuous improvement initiatives to enhance product quality.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in using calipers and reading blueprints.</li><li>Experience in quality assurance practices.</li><li>Minimum of 5 years of quality experience in a metal manufacturing environment.</li><li>At least 5 years of experience operating CMM machines and understanding GD&amp;T.</li><li>Proven experience working with gauges and calipers.</li></ul><h2>Work Environment</h2><p>This is a hands-on environment offering a split shift to support both 1st and 2nd shifts. The typical work schedule is 8:30 AM to 6:00 PM, Tuesday to Saturday, with an option to work on Monday if not scheduled for Saturday.</p><br>

Quality Technician

<p><strong><u>Job Description: </u></strong></p><p>As a Quality Technician, you will play a crucial role in maintaining our high standards of product quality. You will be responsible for ensuring line clearance, performing equipment swabbing after sanitation, and conducting quality audits throughout the production shift.</p><p><br></p><p><strong><u>Responsibilities: </u></strong></p><ul><li>Verify line clearance prior to startup.</li><li>Perform equipment swabbing after sanitation.</li><li>Conduct quality audits for each production line throughout the shift.</li><li>Document in-line process check results per pre-approved specifications.</li><li>Report any Out of Specification (OOS) or non-conformance to production.</li><li>Ensure immediate corrective actions are completed before startup for any non-conformance.</li><li>Label and store non-compliant products in designated areas, following MRB processes.</li><li>Perform periodic quality and GMP audits of the production area, focusing on product handling compliance.</li><li>Audit ingredients staged for manufacturing and ensure no expired materials are used.</li><li>Conduct temperature audits of ingredients, Work In Progress (WIP), and finished products during production.</li><li>Prepare shift reports for the next shift follow-up.</li><li>Perform case count audits on all products.</li><li>Conduct daily Pre-operational Inspections.</li><li>Assist in metal detector validations and regular in-process metal detector line checks.</li><li>Ensure operators follow metal detector Standard Operating Procedures (SOP).</li><li>Report any food safety risks to the supervisor.</li><li>Collect samples from raw materials, in-process, and finished products for lab testing.</li><li>Perform other duties as assigned.</li></ul><p><strong><u>Qualifications:</u></strong></p><ul><li>Associate&#39;s Degree in a relevant field.</li><li>1 year of experience working in quality control. </li><li>Experience working in a food manufacturing environment.</li></ul><p><strong><u>About Actalent</u></strong></p><p>Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.</p><p><br></p><p><strong><u>Diversity, Equity &amp; Inclusion</u></strong></p><p>At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&amp;I Are Embedded Into Our Culture Through:</p><p><br></p><ul><li>Hiring diverse talent</li><li>Maintaining an inclusive environment through persistent self-reflection</li><li>Building a culture of care, engagement, and recognition with clear outcomes</li><li>Ensuring growth opportunities for our people</li></ul><p><br></p>

<h1><strong>Job Title: Quality Technician</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a dedicated Quality Technician to ensure our quality processes are executed with precision. You will perform dimensional, visual, and mechanical inspections, utilizing standard documentation and procedures. Your role will involve using precision measuring tools to provide acceptance or rejection for compliance with established standards and processes.</p><p><br></p><h2>Responsibilities</h2><ul><li>Conduct dimensional, visual, and mechanical inspections and troubleshooting using standard documentation and procedures.</li><li>Utilize precision measuring tools to assess compliance with established standards and processes.</li><li>Verify conformance to applicable procedures and other approved documents.</li><li>Ensure no counterfeit parts are received and activate the process as per procedure in case of an event.</li><li>Prepare procedures, update, and maintain files as needed by AS Standard certification and quality enhancement.</li><li>Interact effectively and professionally with all customers.</li><li>Train and guide new Quality Assurance inspectors and manage QA data, log data, and evaluate results utilizing simple statistical tools.</li><li>Execute knowledge of QA methods and standards, inspection procedures, QA instructions, and assembly specifications.</li><li>Identify procedures to conduct quality inspections.</li><li>Evaluate and interpret manuals, blueprints, specifications, along with other technical data.</li><li>Conduct first article, piece, in-process, and final inspections utilizing different automated and manual equipment.</li><li>Update and maintain inspection documents, forms, logs, conformance certificates, and other records.</li><li>Identify root causes of problems, analyze, and develop remedial actions working with the shop floor.</li><li>Engage in dialogue and interact with suppliers to resolve Non-Conformities.</li><li>Respond to Customer REACH, RoHS, and Conflict Minerals requests. Provide support to the business and develop solutions.</li><li>Assist the business in properly documenting requirements and lead users in developing new SAP functionalities.</li><li>Fulfill other duties and responsibilities as necessary to assist in meeting the needs of the organization to achieve annual goals and objectives.</li></ul><h2>Essential Skills</h2><ul><li>Proficiency in troubleshooting, quality assurance, and quality control.</li><li>Experience in mechanical inspection using tools like calipers.</li><li>Ability to read and interpret blueprints.</li><li>Strong problem-solving skills.</li><li>Excellent communication skills.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Engineering Degree preferred (Associates/Bachelors).</li><li>Excellent negotiating skills.</li><li>Ability to organize and prioritize workload.</li><li>Attention to detail.</li><li>Computer literacy including SAP, MS Word, Excel, and MS Outlook.</li><li>Familiarity with Quality Audit Process and maintenance of Quality Management System.</li></ul><h2>Work Environment</h2><p>Monday through Friday from 8AM to 5PM. </p>

<h3>Quality Technician – Precision, Passion, Performance</h3><p>Are you passionate about precision and driven by the pursuit of excellence? Do you thrive in a hands-on environment where your attention to detail ensures the highest standards of quality? If so, we want you on our team!</p><p>We’re looking for a Quality Technician who’s ready to take ownership of product integrity and play a key role in delivering excellence to our customers. In this role, you’ll be the gatekeeper of quality—inspecting, testing, and verifying that every part and product meets exacting standards.</p><h3>&#128736;️ What You’ll Do</h3><ul><li>Inspect &amp; Test: Examine machined, fabricated, or assembled parts for defects, wear, and deviations from specifications.</li><li>Reject &amp; Report: Identify and discard non-conforming materials, products, or equipment.</li><li>Analyze &amp; Interpret: Use blueprints, manuals, and data to determine inspection methods and specifications.</li><li>Measure &amp; Record: Use tools like calipers, gauges, and micrometers to verify dimensions and document results.</li><li>Collaborate &amp; Improve: Work closely with production teams to ensure continuous quality improvement.</li></ul><h3>&#129504; What You Bring</h3><ul><li>5–7 years of hands-on experience in quality inspection or quality engineering.</li><li>Associate’s degree or equivalent training/experience.</li><li>Strong analytical and problem-solving skills.</li><li>Excellent verbal and written communication.</li><li>Familiarity with raw materials, production processes, and quality control techniques.</li><li>Basic knowledge of tools, machines, and their maintenance.</li></ul><h3>&#127775; Why Join Us?</h3><ul><li>Be part of a team that values craftsmanship and quality.</li><li>Work in a collaborative, innovation-driven environment.</li><li>Make a real impact on the products that reach our customers.</li><li>Enjoy opportunities for growth and professional development.</li></ul>

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