Manager, Quality Engineering (Medical Devices)

Location: Salem, New Hampshire, USA; onsite role with approximately 30% travel to company and customer sites

Company

Medical device manufacturing organization producing components and finished medical devices across multiple sites.

What you will do

• Lead and develop quality engineering, calibration, inspection, and quality team functions across multiple manufacturing locations.
• Provide technical leadership for process validation, risk management, statistical analysis, product and process quality, and continuous improvement.
• Lead nonconformance reviews, CAPA activities, complaint investigations, quality events, and customer-related quality investigations.
• Partner with operations, manufacturing engineering, supply chain, regulatory, and quality systems teams to improve yield, delivery, efficiency, and product quality.
• Drive COPQ, scrap, rework, and recurring-defect reduction using data-driven problem solving and quality metrics.
• Oversee calibration programs, metrology compliance, inspection equipment, new product introductions, process transfers, and capacity expansion readiness.

Requirements

• Bachelor’s degree in engineering or another quality-related technical field.
• Minimum 10 years of experience in quality management.
• Required experience in medical device manufacturing.
• Expert knowledge of quality engineering, root cause analysis, corrective action systems, process risk management, and quality planning.
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, process validation, SPC, DOE, MSA, PFMEA, control plans, Lean, Six Sigma, metrology, and calibration systems.
• Proficiency with Minitab, statistical software, ERP systems, and electronic quality systems, along with strong leadership and cross-functional communication skills.

Nice to have

• Multi-site leadership experience.
• ASQ Certified Quality Engineer or Certified Manager of Quality/Organizational Excellence certification.
• Six Sigma Black Belt or equivalent certification.
• Certified Lead Auditor qualification.

Culture & Benefits

• Leadership culture focused on accountability, collaboration, inclusion, learning, and continuous improvement.
• Regular engagement with manufacturing operations and cross-functional stakeholders.
• Approximately 30% travel and visitation to company and customer sites.
• Reliable, appropriate transportation is required.