Operations Quality Manager- Manufacturing

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 wont just enforce a quality system; youll shape it. Youll 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