Staff Quality Engineer - Actalent

Description:

The Staff Quality Engineer is mainly responsible for providing quality engineering support (with particular focus on post market activities. Other activities may include working with manufacturing, R&D, Marketing, Sales, and other Quality functions to address post market feedback. Also, this position will work with the QMS team to ensure post market processes are appropriately defined, implemented, and maintained.

-Develops, modifies, applies and maintains quality standards.

-Ensures that corrective measures meet acceptable standards and that documentation is compliant with requirements.

-Has 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, as appropriate, 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 or CAPA activities, audit findings, complaint investigations, etc.).

-Identify, analyze, and manage risk through product life cycle with use of FMEA and other risk management tools

-Responsible for reporting on post market metrics

-Lead complaint board meetings

-Prepare, review, and oversee Health Hazard Evaluations (HHE)

-Responsible for executing, monitoring, and overseeing recall process

-Prepare and submit Medical Device Reports (MDR) and/or other regulatory complaint reports as required

-Responsible for complaint determination, investigation, reporting, and closure

Skills & Qualifications:

-Bachelors Degree in Engineering, Science, or technical field with 5+ years of work experience in Engineering and/or Quality.

-Expert with adverse event reporting per 21 CFR 803 and other applicable standards

-Expert with medical device recalls per 21 CFR 806 and other applicable standards

-Proficient with Quality Management Systems (QMS), 21 CFR 820, ISO 13485 standards

-Expert with ISO 14971 and internal risk management process

-Expert with complaint assessment and handling per 21 CFR 820.198 and other applicable standards

About 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.