Sr. Quality Assurance Manager- Medical Devices

Contract Professionals, Inc.; Clinton Charter Township (MI); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Contract Professionals, Inc. partners with a leading medical device manufacturer to recruit a Senior Quality Assurance Manager who will steer the Quality team, oversee the QMS, and drive regulatory compliance.

Based in Clinton Township, MI, this direct-hire, on-site role offers $150,000–$170,000 per year plus relocation assistance. You will mentor staff, manage CAPA, audits, and CI initiatives to ensure product quality.

Qualifications

• 8+ years of progressive QA in regulated manufacturing (medical devices).
• Direct experience leading a QA team in plastic injection molding environment.
• 5+ years in quality management or leadership.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820/QMSR.
• Experience overseeing QMS, CAPA, regulatory audits and compliance.
• Experience with IQ/OQ/PQ and process validation.
• Ability to collaborate with Manufacturing, Engineering and Operations.
• Must meet ITAR eligibility.

Responsibilities

• 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.

Skills

Quality leadership

Regulatory compliance

CAPA & investigations

Process validation

Cross-functional collaboration

Job description

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.

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

What You'll Do

• 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.

What We're Looking For

• 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.

Additional Qualifications

• Experience participating in or leading FDA inspections.
• ASQ certifications (CQE/CQA) or Six Sigma training.
• Experience with cleanroom manufacturing and medical device production documentation.