Title:

Lead Supplier Quality Engineer Location:

Madison, WI (Onsite) Position Overview The Lead Supplier Quality Engineer owns supplier quality management for a well known Medical Device Company's approved supplier base. This role drives supplier qualification, corrective action, and audit programs that ensure incoming materials and outsourced processes meet quality and regulatory requirements. This is a full-time, direct-hire position for a professional seeking a long-term role within our organization. As one of a small number of specialists dedicated to this function, the successful candidate will serve as the organization's primary subject matter expert in supplier quality.

Key Responsibilities Supplier Communication & Partnerships:

Serve as the primary point of contact and relationship manager for suppliers, coordinating technical communication and ensuring timely, responsive engagement on quality matters.

Supplier Qualification & Maintenance:

Assess and classify suppliers by risk category; maintain the Approved Supplier List (ASL) and associated supplier files; lead new supplier qualification activities, including documentation review and the Supplier Assessment Form process.

Supplier Audits:

Plan and lead supplier quality audits (on-site and remote) in accordance with the audit schedule, using risk, criticality, and change history to determine scope. Issue formal audit reports and verify implementation of corrective action plans.

SCAR & Issue Resolution:

Manage the Supplier Corrective Action Request (SCAR) process end-to- end, including initiation through the Material Review Board, tracking Corrective Action Plans (CAPs) against timelines, and verifying effectiveness prior to closure.

Technical Troubleshooting:

Apply engineering expertise to understand supplier manufacturing processes and lead technical troubleshooting of component issues, particularly for machined and electronic/electrical components, ensuring corrective actions are data-driven.

Change Management & Dispositions:

Manage Supplier Change Notifications (SCNs) in collaboration with R&D and Operations; approve Returned Material Authorization (RMA) dispositions and coordinate return of nonconforming products.

Audit Support:

Support internal and external audits, including hosting regulatory and Notified Body/FDA auditors as required. Required Qualifications Minimum of 5 years of quality engineering experience in a regulated manufacturing environment, with a dedicated focus on supplier quality. Candidates with more extensive experience who can operate as an immediate domain expert are encouraged to apply. Bachelor's degree in Engineering or a related technical field (or equivalent combination of education and experience). Ability to work fully on-site daily at the medical device's Madison, WI facility, with regular presence on the manufacturing floor and close collaboration with production teams. Practical, hands-on experience with physical, hardware-based products and the mechanical or electrical literacy required to troubleshoot physical components. Direct, hands-on supplier auditing experience. Working knowledge of ISO 13485 and 21 CFR 820.

• Willingness to travel up to approximately 10% of the time, primarily within the broader Madison region, with occasional peak periods requiring up to 25%. Valid documentation and capability for international travel as business needs evolve. Preferred Qualifications Experience in hardware-based medical devices strongly preferred; candidates with primarily pharmaceutical or biologics backgrounds are less aligned with this role's hardware focus. Quality experience in other regulated, hardware-focused industries (e.g., aerospace, automotive) is welcomed. Automotive candidates should be comfortable adapting from a high-volume to a low- volume, high-complexity manufacturing environment. ASQ certification (CQE, CQA, or equivalent) or

ISO 13485

Lead Auditor certification. Experience hosting Notified Body/Registrar auditors or FDA investigators. Familiarity with ERP systems and eQMS platforms, particularly ComplianceQuest. Awareness of software-supplier audit considerations (secure SDLC, SBOM, vulnerability management) relevant to

IEC 62304

supplier requirements. Work Environment We seek a collaborative, solutions-oriented engineer who partners effectively across departments to identify compliant, business-friendly outcomes. Work is performed primarily in an office and light-manufacturing/lab environment. The role 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 provided in accordance with applicable law.

Pay:

$110,000.00 - $160,000.00 per year

Benefits:

401(k) Health insurance Vision insurance

Work Location:

In person