Operations Quality Manager
$150,000–$200,000 year
On-siteMarlborough, Massachusetts, United States
Job Summary
Lead manufacturing quality operations by directing Quality Engineers and QC Supervisors to ensure product compliance and high operational standards. Oversee in-process inspections, final product acceptance, and lot release activities while owning non-conformance and Material Review Board processes, including investigations, dispositions, and root cause analysis. Drive corrective actions and implement Lean/Six Sigma methodologies to improve process yield and reduce risk. Support new product introductions through risk management and represent the team during internal and external regulatory audits. Provide executive leadership with data-driven reports on quality KPIs and systemic improvements. Maintain strict compliance with ISO 13485, FDA QMSR, and international regulations. Partner cross-functionally with Manufacturing, R&D, and Supply Chain to resolve challenges and monitor vendor performance.
Required Qualifications
- Bachelor's degree in Engineering (Mechanical, Electrical, or related discipline) or equivalent professional experience
- 8+ years of progressive Quality experience within regulated manufacturing (Medical Device, IVD, Aerospace, or Defense), with direct medical device industry experience required
- 3+ years of experience directly managing Quality Engineers and/or QC teams
- Deep experience owning shop-floor quality, NCR/MRB systems, and ISO 13485 / risk-based quality principles
- Ability to travel 5–10% for supplier visits, customer sites, and system testing
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