Lead Supplier Quality Engineer

NeuWave Medical Inc.; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

NeuWave Medical, located in Madison, WI, seeks a Lead Supplier Quality Engineer to own supplier quality management across the approved supplier base. You will drive supplier qualification, corrective actions, and audits to ensure incoming materials and outsourced processes meet quality and regulatory requirements.

The role requires hands-on supplier auditing, ISO 13485 and 21 CFR 820 knowledge, and collaboration with cross-functional teams.

Qualifications

• Bachelor's degree in Engineering or related field.
• 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 Microsoft Office.

Responsibilities

• Assess and classify suppliers by risk; maintain the Approved Supplier List (ASL) and 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; issue the formal Audit Report to the supplier.
• Lead the SCAR process end-to-end — initiating SCARs through the MRB, tracking CAPs against timelines, and verifying effectiveness prior to closure.
• Manage Supplier Change Notifications (SCNs) with cross-functional teams (R&D, Operations).
• Approve Returned Material Authorization (RMA) dispositions and coordinate return of nonconforming supplier product.
• Support internal and external audits, including hosting regulatory and Notified Body auditors as needed.

Skills

Supplier quality

Auditing

Quality engineering

Regulatory knowledge

MS Office

Education

Bachelor's degree in Engineering

Tools

ERP systems (ComplianceQuest)

Job description

Position Summary

The Lead Supplier Quality Engineer owns supplier quality management for NeuWave 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.

Brief Description

Position Summary

The Lead Supplier Quality Engineer owns supplier quality management for NeuWave 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.

Key Responsibilities

• 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.

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 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).

Preferred Qualifications

• 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 ComplianceQuest, is a plus.
• Familiarity with software-supplier audit considerations (secure SDLC, SBOM, vulnerability management) relevant to IEC 62304-related supplier requirements.

Travel Requirements

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

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.