Operations Quality Manager- Manufacturing

Why This Role

Join a growing medical device manufacturer in Littleton, MA as our next Operations Quality Manager — a role built for a hands-on quality leader who wants real ownership over how products get made, inspected, and shipped. You won't just enforce a quality system; you'll shape it. You'll lead a talented team of Quality Engineers and a QC Supervisor, partner directly with Manufacturing and Engineering leadership, and drive the continuous improvement work that keeps a growing operation running at the highest standard.

If you thrive at the intersection of people leadership, regulatory rigor, and operational problem-solving, this is a role where your fingerprints will be on every product that leaves the floor.

• Lead all manufacturing-related quality activities across production operations, setting the standard for how quality shows up on the floor every day.
• Oversee in-process inspection, final inspection, product acceptance, and release activities, ensuring every product meets spec before it ships.
• Manage and mentor Quality Engineers, the QC Supervisor, and the broader inspection team, building a group people want to work for.
• Own the NCR/MRB process end-to-end — investigation, disposition, trending, and timely closure — turning nonconformances into insight.
• Drive CAPA and corrective actions based on manufacturing quality trends and root cause analysis, fixing problems at the source.
• Lead continuous improvement initiatives focused on quality, yield, efficiency, and risk reduction — your ideas will directly move the needle.
• Apply Lean, Six Sigma, and other process improvement methodologies to make operations measurably better.
• Support new product, equipment, and manufacturing process introductions through quality planning and risk management, getting involved from day one of launch.
• Ensure compliance with FDA QMSR, ISO 13485, and applicable international regulations, keeping the site audit-ready at all times.
• Support internal and external audits, including FDA and notified body inspections, representing the quality function with confidence.
• Partner closely with Manufacturing, Engineering, Supply Chain, and Operations to resolve issues and improve processes as one team.
• Support supplier quality activities related to manufacturing and incoming material performance.
• Deliver data-driven reporting to leadership on quality performance, risks, trends, and improvement initiatives — your voice will help shape strategic decisions.
• Coach and develop the manufacturing Quality team while building a strong, lasting culture of quality.

• 8+ years of relevant quality experience in a manufacturing environment (medical devices strongly preferred).
• Proven experience leading and developing a quality team, including QC/inspection staff.
• Strong working knowledge of FDA QMSR, ISO 13485, and international regulatory requirements.
• Hands-on experience with NCR/MRB processes, CAPA, and root cause investigation.
• Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.
• Experience supporting FDA and notified body audits.
• High school diploma or equivalent required.
• A collaborative, data-driven mindset and the leadership presence to influence across Manufacturing, Engineering, Supply Chain, and Operations.

• Competitive compensation with a 10% annual target bonus
• Health, vision, and dental insurance
• 401(k) with company match
• Life insurance
• Comprehensive paid leave
• A flexible working environment

• Location: Littleton, MA (relocation assistance not provided)
• Experience Level: Mid-senior
• Education: High school diploma or equivalent
• Openings: 1