• Industry: Medical Devices / Healthcare Technology • Experience Level: Mid-Senior (8+ Years) • Job Function: Engineering / Quality Management • Education Level: Bachelor's Degree or Equivalent • Location: Greater Boston Area / Eastern Massachusetts • Relocation Assistance: No • Compensation: Competitive Salary + 10% Annual Target Bonus Position Overview We are seeking an experienced Operations Quality Manager to join a leading medical device manufacturing organization in Eastern Massachusetts. This leadership role is responsible for overseeing day-to-day manufacturing quality operations, managing the Quality Engineering and QC Supervision teams, and driving continuous improvement initiatives across production. Key Responsibilities • Quality Leadership: Lead all manufacturing-related quality activities, ensuring product compliance and high operational standards. • Team Management: Direct and mentor Quality Engineers, QC Supervisors, and inspection personnel to foster a strong culture of quality. • Inspection & Release: Oversee in-process inspections, final product acceptance, and lot release activities. • NCR & MRB Management: Own non-conformance (NCR) and Material Review Board (MRB) processes, including investigations, dispositions, and root cause analysis. • CAPA & Continuous Improvement: Drive corrective actions (CAPA) and implement Lean/Six Sigma methodologies to improve process yield, reduce risk, and boost efficiency. • NPI & Quality Planning: Support new product and manufacturing process introductions through risk management and quality planning. • Regulatory Compliance: Maintain strict compliance with ISO 13485, FDA QMSR, and international medical device regulations. • Audit Support: Represent manufacturing quality during internal and external regulatory/notified body audits. • Cross-Functional Collaboration: Partner with Manufacturing, R&D/Engineering, and Supply Chain to resolve quality challenges and monitor vendor material performance. • Reporting: Provide executive leadership with data-driven reports on quality KPIs, risk trends, and systemic improvements. Must-Have Qualifications • Education: Bachelor's degree in Engineering (Mechanical, Electrical, or related discipline) or equivalent professional experience. • Experience: 8+ years of progressive Quality experience within regulated manufacturing (Medical Device, IVD, Aerospace, or Defense), with direct medical device industry experience required. • Leadership: 3+ years of experience directly managing Quality Engineers and/or QC teams. • Technical Expertise: Deep experience owning shop-floor quality, NCR/MRB systems, and ISO 13485 / risk-based quality principles. • Travel: Ability to travel 5–10% for supplier visits, customer sites, and system testing. Benefits Package • Competitive base salary • 10% annual performance bonus • Comprehensive health, vision, and dental insurance • 401(k) retirement plan with company match • Life insurance coverage • Generous paid time off (PTO) and leave options • Flexible working environment