Lead Supplier Quality Engineer

Position Summary

The Lead Supplier Quality Engineer owns supplier quality management for Neu Wave Medical's approved supplier base, driving supplier qualification, corrective action, and audit programs that ensure incoming materials and outsourced processes meet quality and regulatory requirements.

The Lead Supplier Quality Engineer owns supplier quality management for Neu Wave Medical's approved supplier base, driving supplier qualification, corrective action, and audit programs that ensure incoming materials and outsourced processes meet quality and regulatory requirements.

• Assess and classify suppliers by risk category; maintain and update the Approved Supplier List (ASL) and individual supplier files.
• Conduct initial supplier qualification evaluations and periodic re-evaluations; coordinate the Supplier Assessment Form process for new suppliers.
• Lead supplier quality audits (on-site and remote) per the audit schedule, using risk, criticality, and change history to set scope; issue the formal Audit Report to the supplier.
• Lead the Supplier Corrective Action Request (SCAR) process end-to-end — initiating SCARs through the Material Review Board, tracking supplier Corrective Action Plans (CAPs) against required timelines, and verifying corrective action effectiveness prior to closure.
• Manage Supplier Change Notifications (SCNs) in partnership with cross-functional teams (R&D, Operations).
• Approve Returned Material Authorization (RMA) dispositions and coordinate physical return of nonconforming supplier product as needed.
• Support internal and external audits, including hosting regulatory and Notified Body auditors as needed.

• 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 supplier quality.
• Direct, hands-on supplier auditing experience (required).
• Working knowledge of ISO 13485 and 21 CFR 820.
• Proficient with standard office software (Microsoft Office suite or equivalent).

• ASQ certification (CQE, CQA, or equivalent).
• ISO 13485 Lead Auditor certification.
• 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.
• Familiarity with software-supplier audit considerations (secure SDLC, SBOM, vulnerability management) relevant to IEC 62304-related supplier requirements.

Up to 25%, primarily for on-site supplier audits.

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.