Lead Manufacturing Quality Engineer

The Lead Manufacturing Quality Engineer owns manufacturing quality engineering for Neu Wave Medical's Madison operations, including process validation, nonconformance management, product release, and equipment qualification, ensuring sterile single-use probes and capital consoles are manufactured in compliance with the QMS.

Key Responsibilities

• Own and maintain the Master Validation Plan (MVP); review and approve IQ/OQ/PQ and Test Method Validation (TMV) protocols and reports.
• Confirm validation status is documented prior to use of equipment or processes in production, and evaluate revalidation requirements upon change.
• Coordinate identification, review, investigation, and disposition of nonconforming product and process nonconformances; maintain the Nonconformance Report (NCR) Log.
• Convene and chair Material Review Board (MRB) disposition reviews; review and approve rework instructions and confirm post-rework verification is completed prior to release.
• Determine and document whether nonconformances require escalation to CAPA.
• Approve release of finished devices per established quality procedures; support equipment qualification and calibration programs.
• Support internal and external audits related to manufacturing quality, including hosting regulatory and Notified Body auditors as needed.

Required Qualifications

• Bachelor's degree in Engineering or a related technical field (or equivalent combination of education and experience).
• 5+ years of quality engineering experience at a medical device manufacturer, with a focus on manufacturing/process quality.
• Working knowledge of ISO 13485 and 21 CFR 820.
• Demonstrated experience with internal and/or external quality audits.
• Proficient with standard office software (Microsoft Office suite or equivalent).

Preferred Qualifications

• ASQ certification (CQE, CRE, or equivalent).
• Experience hosting Notified Body/Registrar auditors or FDA investigators during on-site inspections is a plus.
• Experience with ERP systems and eQMS platforms, specifically Compliance Quest, is a plus.

Travel Requirements

Less than 10%.

Work Environment & Physical Demands

Work is primarily performed in an office and light-manufacturing/lab environment at Neu Wave 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.

Neu Wave 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.