Operations Quality Manager (3764)
$145,000–$160,000 year
On-siteLittleton, Massachusetts, United States
Littleton, Massachusetts, United StatesOn-siteFull Time$145,000–$160,000 yearSenior LevelBachelors Degree
Full TimeSenior LevelBachelors Degree
Job Summary
Senior Operations Quality Manager to own manufacturing quality, drive CAPA and NCR, lead QA/RA collaborations, oversee QC/QA teams, apply Lean/Six Sigma, ensure compliance with FDA QMSR and ISO 13485, support internal/external audits, mentor team, and implement quality improvements on the production floor.
Required Qualifications
- Bachelor’s degree in Engineering or related discipline
- 8+ years of progressive Quality experience in medical device manufacturing
- 3+ years managing Quality Engineers and/or QC teams
- Experience owning Manufacturing Quality, NCR/MRB processes, and shop-floor execution
- Strong knowledge of ISO 13485, and risk-based quality principles
- Demonstrated independent decision-making in fast-paced manufacturing environments
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