Senior Quality Assurance Manager, Medical Devices

Job overview

The Senior Quality Assurance Manager, Medical Devices role is full-time and onsite in Charter Township of Clinton, MI, with compensation of $150,000–$170,000 per year. The position leads the Quality team at an established medical device manufacturer; relocation assistance is available. The role exists to oversee quality systems, regulatory compliance, and continuous improvement in medical device manufacturing. It contributes to product quality and operational performance by leading the Quality team, managing audits and corrective actions, and partnering with Engineering, Manufacturing, and Operations.

What you'll do

• Lead, mentor, and develop the Quality team and oversee daily Quality operations
• manage and improve the QMS
• ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, and applicable requirements
• oversee CAPA investigations, nonconformances, complaints, and corrective actions
• lead or participate in audits
• oversee IQ/OQ/PQ process validation
• partner with Engineering, Manufacturing, and Operations
• drive continuous improvement initiatives.

What we're looking for

Skills & competencies

senior quality assurance manager

medical devices

quality management system

iso 13485

fda 21 cfr part 820

capa

regulatory audits

plastic injection molding

clinton township mi

$150k–$170k

relocation assistance

Work arrangement

• Weekend coverage required

Benefits & perks

• Relocation assistance available.

Why this role

Requires direct experience leading a Quality team in a medical device plastic injection molding environment; relocation assistance is available.

About the employer

Contract Professionals, Inc. is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.