Sr. Quality Assurance Manager

Senior Quality Assurance Manager Clinton Township, MI Direct Hire | Full-Time | On-Site $150, 000–$170, 000 + Excellent Benefits

Are you an experienced Quality leader with a strong background in medical device manufacturing, ISO 13485, FDA compliance, and Quality Management Systems? We're partnering with an innovative manufacturer seeking a Senior Quality Assurance Manager to lead Quality strategy, regulatory compliance, and continuous improvement initiatives across the organization. This is an excellent opportunity to make a significant impact while leading a talented quality team in a highly regulated manufacturing environment.

• Lead and continuously improve the company's Quality Management System (QMS).
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, ITAR, and customer requirements.
• Oversee CAPA, nonconformances, customer complaints, audits, validations, and regulatory compliance.
• Serve as the primary Quality representative during customer, certification, and regulatory audits.
• Lead, mentor, and develop the Quality team while partnering with Engineering, Manufacturing, and Operations.
• Drive continuous improvement initiatives that enhance product quality, compliance, and operational performance.

• 8+ years of Quality experience in a regulated manufacturing environment
• Leadership experience managing Quality teams
• Strong experience with: ISO 13485 FDA 21 CFR Part 820 / QMSR CAPA Internal & External Audits Validation (IQ/OQ/PQ) Quality Management Systems Medical device manufacturing experience
• Highly Preferred:
  Plastic injection molding experience
• ITAR experience
• ASQ Certification (CQE/CQA) or Six Sigma