Quality Engineer (Post Market)Job DescriptionThe Staff Quality Engineer is mainly responsible for providing quality engineering support with a particular focus on post market activities. This position will also work with manufacturing, R&D, Marketing, Sales, and other Quality functions to address post market feedback. Additionally, the role involves ensuring that post market processes are appropriately defined, implemented, and maintained in conjunction with the QMS team.Responsibilities
Develop, modify, apply, and maintain quality standards.
Ensure that corrective measures meet acceptable standards and that documentation is compliant with requirements.
Have the authority to stop any potential non-conforming processing, shipments, and manufacturing, and escalate to Quality Management and/or Executive Management.
Apply and understand statistical methodologies for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.
Lead and/or participate in corrective/preventive action teams in resolving production, customer, and supplier issues (e.g., nonconformances, CAPA activities, audit findings, complaint investigations, etc.).
Identify, analyze, and manage risk through the product life cycle using FMEA and other risk management tools.
Report on post market metrics.
Lead complaint board meetings.
Prepare, review, and oversee Health Hazard Evaluations (HHE).
Execute, monitor, and oversee the recall process.
Prepare and submit Medical Device Reports (MDR) and/or other regulatory complaint reports as required.
Handle complaints from intake to closure.
Manage nonconformances and investigations, including CAPA and Health Hazard Evaluations.
Essential Skills
Bachelor’s Degree in Engineering preferred but experience is highly valued.
5+ years of relevant experience preferred.
Experience preparing and submitting MDR for US.
Experience with the complaint handling process including opening and closing a case
Proficient in documenting in electronic systems (e.g., Webtrader).
Expertise in adverse event reporting per 21 CFR 803 and other applicable standards.
Expertise in medical device recalls per 21 CFR 806 and other applicable standards.
Proficient with Quality Management Systems (QMS), 21 CFR 820, ISO standards, and internal risk management processes.
Expertise in complaint assessment and handling per 21 CFR 820.198 and other applicable standards.
Additional Skills & Qualifications
Experience with complaint handling from intake to closure.
Experience with nonconformances, investigations, CAPA
Experience in preparing, reviewing, and overseeing Health Hazard Evaluations (HHE).
Work EnvironmentOn-Site, ContractAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.