Senior Operations Quality Manager - Medical Devices

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

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.