Quality Engineer

Description

KEY PURPOSE OF ROLE

Quality Engineer will support all quality teams with knowledge in quality systems and continuous improvement while assuring compliance with regulatory requirements for FDA and ISO standards. The Quality Engineer is responsible for developing, preparing the installation, and/or revising test validation procedures/protocols to ensure the appropriate regulatory agency validation requirements, internal company standards, and current industry practices manufacture the product. The Quality Engineer reports to the Quality Manager.

KEY RESPONSIBILITIES

• Support new and transferred products by leading efforts of implementation of methods and procedures for inspecting, testing, and evaluating product including executing line trials, process risk analysis; and participating in design and process validations to determine appropriate sampling plans for validations and routine production

• Interfaces with personnel in Quality Control, Quality Assurance, Operations, Engineering, Customer Service, Maintenance, and R&D teams to design, plan, write protocols, execute document results, writes reports, and gain the required approvals for all validation activities. Validation activities include, but are not limited to, product processing, product packaging, and utilities.

• Maintains the cleaning validation matrix and evaluates new products against the matrix to determine the level of validation required.

• Collaborates with Operations, Engineering, and R&D and manages all Qualification activities for newly purchased equipment (Installation, Operational Qualification). Develops and maintains validation master plan, qualification, and validation schedule. Ensures FDA regulatory guidelines structure validation/qualification projects and timelines. Informs Quality Management of validation projects on a regular basis.

• Resolve difficult technical issues during product and process development using statistical techniques and analysis to improve the Quality system.

• Performs Risk Management activities, including FMEA’s

• Recommends and initiates specification and process changes based on a statistical analysis of products to ensure the product’s safety, efficacy, and quality.

• Review, develop, revise, and approve quality-related documents as needed.

• Manage the lab with two direct reports

• Manage and track the accelerated and real-time stability samples

• Draft summary reports of the results and share them with the customers

• Monitor stability results and alert R&D if results are out of spec

• Support internal and external compliance audits with regulatory agencies and be the subject matter expert for the validation and risk management programs.

• Serves as an auditor for internal audits.

• Assist in investigations regarding product complaints and correct/preventive actions.

• Assists the quality teams as needed actions, reviews, and implementation procedures.

• Conducts training of personnel as needed.

• Performs other work-related duties as assigned by the Quality Manager.

.

VIRTUES AND TALENTS

The role incumbent will demonstrate the relevant talents for the role and will display the virtues aligned with our principles:

Essential Skills/Experience/Qualifications:

Essential Skills:

• Maintain the integrity of the quality system, product design, and customer product requirements while maintaining a culture of customer focus.

• Enforce a culture of compliance and performance to the quality management system and regulatory requirements.

• Strong problem-solving and statistical analysis skills using a variety of quality engineering tools such as fish-bone, Pareto charts, C&E matrix, hypothesis testing, control charting, ANOVA, DOE, sampling methods, and process capability

• Project specification, justification, and change management

• Can implement and execute continuous improvement initiatives using Lean Six Sigma principles

• Medical Device Regulations Knowledge; FDA 21 CFR 820, ISO13485, ISO9001, and GMP experience

• Project management with excellent report writing and presentation skills

Essential experience:

• Working knowledge of FDA 21 CFR Parts 820, ISO 13485, and ISO 14971 preferred.

• Practical experience in successfully managing multiple projects simultaneously.

• Demonstrated performance and application of Design Control, particularly regarding Medical Devices.

• Ability to read, analyze and interpret standard scientific and technical information.

• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the Mativ HC sites.

• Ability to effectively present information to Team Members with an emphasis on training.

• Ability to comprehend and apply principles of statistics with demonstrated application of statistical theory and sampling plans (e.g., SPC, Cpk/Ppk, PPAP, AQL, OC curves, etc.) preferred.

• Ability to define the problem, collect data, establish facts, and draw valid conclusions.

Essential Qualifications:

• Previous Quality Engineering experience in the Medical Device manufacturing industry in compliance with 21 CFR 820, ISO 9001, MDD, and ISO 13485.

• Experience in Medical Device manufacturing would be a distinct advantage.

• Bachelor’s degree in engineering/chemistry, physics, Biology, or Natural Sciences

• PC literate with good communication skills, both verbal and written. Minitab statistical analysis.

• The ability to work using initiative when required but also showing aptitude as a team player.

Desirable Skills/Experience/Qualifications:

• Certified Quality Engineer

• Risk Management – 14971, ISO13485, and ISO9001

• Familiarity with Pressure Sensitive Adhesive Tapes standards and procedures in a quality control environment, including laboratory testing.

WORK ENVIRONMENT / PHYSICAL DEMANDS

The physical demands described here must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this job, the employee is frequently required to sit and talk or hear and can lift to 20 lbs. The employee is occasionally required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls.

Specific vision abilities required by this job include close vision, distance vision, and color vision.