Senior Supplier Quality Engineer - Medical Devices

Medasource; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

Medasource is seeking a Lead Supplier Quality Engineer to own supplier quality management for a well-known medical device organization in Madison, WI. Responsibilities include qualification, audits, SCAR/CAP processes, and regulatory readiness.

This is a long-term, on-site, direct-hire role for a dedicated professional. The role requires 5+ years in regulated manufacturing, ISO 13485/21 CFR 820 knowledge, and travel up to 10% (peak periods up to 25%).

Qualifications

• 5+ years of quality engineering in a regulated manufacturing environment with a focus on supplier quality.
• Bachelor's degree in Engineering or related technical field.
• On-site daily work at the Madison, WI facility with close collaboration with production teams.
• Working knowledge of ISO 13485 and 21 CFR 820; travel up to 10% (up to 25% during peak) and international travel capability.

Responsibilities

• Serve as the primary contact for suppliers, coordinating technical communication on quality matters.
• Qualify and maintain the Approved Supplier List (ASL) and lead new supplier qualification activities.
• Plan and lead supplier quality audits (on-site and remote) and issue audit reports.
• Manage the SCAR process end-to-end and track CAPs against timelines.
• Apply engineering expertise to troubleshoot hardware components and drive data-driven corrective actions.
• Manage Supplier Change Notifications (SCNs) with R&D and Operations; approve RMAs.
• Support internal and external audits, hosting Notified Body/FDA auditors as required.

Skills

Supplier quality

Quality engineering

Regulatory compliance

Audits & CAPs

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

ComplianceQuest

ERP systems

Job description

Medasource is seeking a Lead Supplier Quality Engineer to own supplier quality management for a well-known medical device organization in Madison, WI. Responsibilities include qualification, audits, SCAR/CAP processes, and regulatory readiness.

This is a long-term, on-site, direct-hire role for a dedicated professional. The role requires 5+ years in regulated manufacturing, ISO 13485/21 CFR 820 knowledge, and travel up to 10% (peak periods up to 25%).