Sr Quality Engineer - Exempt

The Senior Quality Engineer will be responsible for providing quality engineering oversight for design changes to released medical devices, ensuring continued compliance with applicable regulatory requirements and internal standards. While this role does not support day-to-day manufacturing operations, a strong understanding of manufacturing processes (e.g., injection molding, ultrasonic welding, etc.) is essential for evaluating the impact of design changes on product quality and process capability.
Responsibilities

• Represent the Released Product Management (RPM) Design Quality team on projects addressing day-to-day quality issues of market-released products.
• Ensure compliance with RPM activities per applicable Standard Operating Procedures (SOPs) and External Standards.
• Contribute to and lead activities including risk analysis, product risk assessment, Failure Mode and Effects Analysis, and assessing specific product issues for impact on patient and user safety and product quality.
• Conduct drawing and specification reviews, verification and validation testing and reporting, product performance reviews, and test method validation.
• Perform DHF audits and mechanical drawing review and approval per ASTM-14.5Y.
• Engage in technical problem-solving, compile data, prepare reports on findings to identify trends, and propose corrective action as needed.
• Collaborate with RPM project cross-functional teams to ensure quality standards are in place.
• Specialize in RPM risk management, test method validation, and equipment calibration/qualification/validation.

• CAPA
• Medical Device
• Risk Management
• RPM Quality

• 10 Years design experience in the medical device industry, Class III experience helpful, but not required
• Kaizen Lean Six Sigma Certified
• Experience in Complaint Handling, Regulatory Reporting, FCA, FDA, and/or CAPA
• PMP Certification or other formal Project Management training and experience
• Program Management/Project Management

• Manufacturing experience
• Medical device risk management
• Compliance effective oversight