Operations Quality Lead - Hands-On Medical Devices

NeuWave Medical Inc.; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

NeuWave Medical in Madison, WI, seeks an Operation Quality Manager to lead the operations quality team and own quality activities across procurement and production of saleable product. This hands-on management role combines strategic leadership with practical quality engineering work to support workload.

You will ensure compliance with 21 CFR 820, ISO 13485, and EU MDR, oversee supplier qualification and internal audits, and collaborate with Operations and Supply Chain to advance quality across

Qualifications

• Bachelor's degree in Engineering or a related technical field preferred; extensive relevant experience may substitute.
• 10+ years of experience in medical device manufacturing, including prior people-management experience.
• Demonstrated leadership of supplier quality and/or manufacturing quality functions.
• Working knowledge of ISO 13485, 21 CFR 820, and EU MDR requirements.
• Proficient with standard office software (Microsoft Office suite or equivalent).

Responsibilities

• Lead the Operations Quality team, including Supplier Quality Engineers, Manufacturing Quality Engineers, and Quality Technicians — setting goals, managing performance, and developing team members.
• Personally perform hands-on quality engineering and inspection work as needed to support team workload and maintain technical proficiency across the functions supervised.
• Own all quality activities related to the procurement and production of saleable product, ensuring compliance with 21 CFR 820, ISO 13485, and EU MDR requirements.
• Oversee the supplier qualification, SCAR, and supplier audit programs led by the Supplier Quality function.
• Oversee process validation, nonconformance management, and product release activities led by the Manufacturing Quality function.
• Oversee the incoming, in-process, and finished device inspection programs and the calibration program performed by Quality Technicians.
• Partner with Operations, Supply Chain, and Manufacturing Engineering leadership on quality risk related to procurement and production.
• Support internal and external audits (Notified Body/Registrar, FDA) related to operations quality, including hosting auditors as needed.
• Report operations-quality metrics and trends to the Head of Quality and contribute to quality system management reviews.

Skills

Leadership

Quality Engineering

Regulatory Compliance

Cross-functional Collaboration

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

ERP Systems

eQMS (ComplianceQuest)

Job description

NeuWave Medical in Madison, WI, seeks an Operation Quality Manager to lead the operations quality team and own quality activities across procurement and production of saleable product. This hands-on management role combines strategic leadership with practical quality engineering work to support workload.

You will ensure compliance with 21 CFR 820, ISO 13485, and EU MDR, oversee supplier qualification and internal audits, and collaborate with Operations and Supply Chain to advance quality across