Operations Quality Manager- Manufacturing

Nexusgtalent; Littleton (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Nexusgtalent is seeking an Operations Quality Manager in Littleton, MA to lead manufacturing quality activities, mentor engineers, and own the NCR/MRB process. You will drive CAPA, lead lean initiatives, and ensure FDA QMSR/ISO 13485 compliance, partnering with cross-functional teams to deliver safe, reliable products.

Ideal candidates have 8+ years in manufacturing quality, strong leadership, and a data-driven mindset with experience supporting FDA and notified body audits.

Qualifications

• 8+ years of quality experience in a manufacturing environment (medical devices preferred).
• Proven leadership of quality teams incl. QC/inspection staff.
• Strong working knowledge of FDA QMSR and ISO 13485.
• Hands-on NCR/MRB, CAPA, and root-cause investigations.
• Experience supporting FDA and notified body audits.
• Collaborative, data-driven mindset and cross-functional influence.

Responsibilities

• Lead manufacturing-related quality activities on the floor.
• Oversee in-process and final inspections and product release.
• Mentor Quality Engineers, QC Supervisor, and inspection team.
• Own NCR/MRB end-to-end investigations and closures.
• Drive CAPA based on trends and root cause analysis.
• Lead continuous improvement initiatives for quality and yield.
• Apply Lean and Six Sigma methodologies.
• Support new product introductions with quality planning.
• Ensure FDA QMSR, ISO 13485 compliance; prepare for audits.
• Partner with Manufacturing, Engineering, Supply Chain to resolve issues.
• Deliver data-driven quality performance reporting.
• Coach manufacturing quality team and build culture.

Skills

Quality leadership

Regulatory compliance

CAPA & RCA

Lean Six Sigma

Audit experience

Team leadership

Education

High school diploma or equivalent

Job description

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.

What You'll Do

• 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.

What You Bring

• 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.

What's In It for You

• 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

The Details

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