Senior Supplier Quality Engineer – Medical Devices & Audits

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

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.