Senior Operations Quality Manager - Medical Devices

Kids for the Future; Madison (WI); On-site; USD 120,000 - 160,000; Full time

Job summary

NeuWave Medical is seeking an Operations Quality Manager in Madison, WI to lead the operations quality team, including Supplier Quality Engineers, Manufacturing Quality Engineers, and Quality Technicians. The role combines leadership with hands-on quality engineering to support ongoing workload.

You will own quality activities across procurement and production, ensuring compliance with 21 CFR 820, ISO 13485, and EU MDR, while guiding supplier audits and product release processes.

Qualifications

• Bachelor's degree in Engineering or related technical field (extensive substitute allowed).
• 10+ years in medical device manufacturing with people management.
• Experience leading supplier/manufacturing quality functions.
• Working knowledge of ISO 13485, 21 CFR 820, EU MDR.
• Proficient with standard office software (Microsoft Office).

Responsibilities

• Lead the Operations Quality team and set performance goals.
• Perform hands-on quality engineering and inspections as needed.
• Own quality activities for procurement and production of saleable product.
• Oversee supplier qualification, SCAR, and supplier audits.
• Oversee process validation, nonconformance management, and product release.
• Oversee inspection programs and calibration by Quality Technicians.
• Partner with Operations, Supply Chain, and Manufacturing Engineering.
• Support audits from Notified Bodies and FDA, hosting auditors.
• Report metrics and trends to Head of Quality.

Skills

Leadership

Quality engineering

Regulatory knowledge

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related technical field

Tools

ComplianceQuest

ERP systems

Microsoft Office

Job description

NeuWave Medical is seeking an Operations Quality Manager in Madison, WI to lead the operations quality team, including Supplier Quality Engineers, Manufacturing Quality Engineers, and Quality Technicians. The role combines leadership with hands-on quality engineering to support ongoing workload.

You will own quality activities across procurement and production, ensuring compliance with 21 CFR 820, ISO 13485, and EU MDR, while guiding supplier audits and product release processes.