Quality Manager - Medical Device

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Ready to lead quality excellence in a fast-moving, innovation-driven environment? We're searching for a Quality Manager to own product quality, strengthen the Quality System, and drive cross-functional compliance from design through distribution.

Responsibilities

• Own core Quality System processes (CAPA, DHR/DMR, calibrations, design transfer/changes, MRB).
• Lead the U.S. site quality team and maintain audit readiness.
• Support quality activities from development through manufacturing and distribution.
• Lead investigations, root-cause analysis, and continuous improvement efforts.
• Oversee sterilization validation, environmental monitoring, and QMS compliance.
• Partner with cross-functional teams including Operations, Engineering, R&D, and Supply Chain.
• Manage supplier qualification, monitoring, and first-article inspections.

Qualifications

• Bachelor’s degree and 5–7 years of medical device experience.
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR 820 (QSR/QMSR), and EU MDR.
• Experience with audits, design transfer, design changes, and risk management.
• Supplier quality and electronic document control experience preferred.

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Full-time

• Job function
  
  Quality Assurance
• Industries Medical Equipment Manufacturing, Manufacturing, and Hospitals and Health Care

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