Sr. Quality Assurance Manager- Medical Devices

We're partnering with an established medical device manufacturer seeking an experienced Senior Quality Assurance Manager to lead its Quality team and oversee quality systems, regulatory compliance, and continuous improvement initiatives.

This position requires a strong background in medical device manufacturing and direct experience leading Quality teams within a plastic injection molding environment.
 

Location: Clinton Township, MI (Macomb County)
Employment: Direct Hire | Full-Time | On-Site
Compensation: $150,000–$170,000
Relocation Assistance Available

• Lead, mentor, and develop the Quality team, including oversight of daily Quality operations.

• Manage and continuously improve the Quality Management System (QMS).

• Ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, and applicable regulatory and customer requirements.

• Oversee CAPA investigations, nonconformances, customer complaints, and corrective actions.

• Lead and participate in customer, certification, and regulatory audits.

• Oversee process validation activities, including IQ/OQ/PQ, documentation, and compliance.

• Partner with Engineering, Manufacturing, and Operations to address quality concerns and improve manufacturing processes.

• Drive continuous improvement initiatives that support product quality and operational performance.

• 8+ years of progressive Quality experience in regulated manufacturing, including medical device manufacturing.

• Direct experience leading a Quality team within a medical device plastic injection molding environment.

• 5+ years of Quality management or leadership experience.

• Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820/QMSR.

• Experience overseeing Quality Management Systems (QMS), CAPA, regulatory audits, and compliance.

• Experience with process validation, including IQ/OQ/PQ.

• Ability to collaborate effectively with Manufacturing, Engineering, and Operations teams.

• Must meet applicable ITAR eligibility requirements.

• Experience participating in or leading FDA inspections.

• ASQ certifications (CQE/CQA) or Six Sigma training.

• Experience with cleanroom manufacturing and medical device production documentation.

If you have experience leading Quality teams in medical device plastic injection molding, I'd welcome the opportunity to connect and share more about the position.