• Participate in project teams to review and develop clear and concise user requirements, product specifications, plans, usability studies, design verification and validation studies, risk management file and other relevant design control deliverables.
• Lead test method validation for design verification and validation.
• Interpret data and convey results; create statistical models; calculate sample sizes/sample plans for testing research hypotheses; and conduct data analyses to support ongoing projects.
• Demonstrate mastery and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
• Act as Risk Management Champion and lead the implementation and development of product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs) that comply with EN ISO 14971.
• BS degree or equivalent
• 5 – 10 years quality engineering experience within the Medical Device Industry
• Strong understanding of Quality Systems Regulations (QSR 21 CFR Part 820, MDD/MDR, and ISO13485)
• ASQ or DFSS certification a plus
• Strong understanding of Risk Management, Product Life Cycle, UDI, PDP process, EU market release and packaging
• Familiarity with injection molding and molding defects a plus
Inquiries and resumes to: Kathy Provost at email@example.com OR 978/952-6425
For more information, please visit https://www.agilesearchinc.com/