Operation Quality Manager NeuWave Medical, Inc - 3.5 Madison, WI Job Details 22 hours ago Qualifications Managing medical device teams Computer operation Manufacturing facility experience Managing engineering teams Medical device manufacturing facility experience Biomedical regulatory compliance Productivity software Manufacturing

ISO 13485 FDA

regulations Full Job Description Position Summary The Operation Quality Manager leads NeuWave Medical's operations quality team — Supplier Quality Engineers, Manufacturing Quality Engineers, and Quality Technicians — and owns all quality activities related to the procurement and production of saleable product. This is a working manager role: in addition to setting team goals, managing performance, and developing team members, this role personally performs hands-on quality engineering work as needed to support team workload. Key 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 (e.g., supplier audits, process validation activities, nonconformance investigations, incoming/in-process/final inspection) 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. Required 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). Preferred Qualifications ASQ certification (CQE, CQM, or equivalent).

ISO 13485

Lead Auditor certification. Experience with ERP systems and eQMS platforms, specifically ComplianceQuest. Experience hosting Notified Body/Registrar auditors or FDA investigators during on-site inspections. Travel Requirements Less than 10%. Work Environment & Physical Demands Work is primarily performed in an office and light-manufacturing/lab environment at NeuWave Medical's Madison, WI facility. Requires the ability to sit or stand for extended periods, use a computer workstation, and occasionally lift up to 25 lbs. Reasonable accommodations will be made for individuals with disabilities to perform essential job functions. Equal Employment Opportunity NeuWave Medical (a Precision IO Group company) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other status protected by applicable law.