Senior Medical Device QA Leader — ISO 13485, QMS, CAPA (On-Site)

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

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.