Supplier Quality Engineer

Based in Madison, WI, we are a global leader in radiotherapy and radiosurgery solutions, dedicated to transforming cancer treatment with innovative technologies that improve patient outcomes. With over 30 years of innovation and 1,000+ systems installed worldwide, we push the boundaries of what’s possible in radiation therapy. Join us in making a direct impact on patients’ lives!

1. Strong compensation and benefits
2. Amazing team, work environment, and company culture
3. Great vertical mobility and career growth potential!

Key Responsibilities:

• Maintain the Approved Supplier List (ASL) and evaluate new suppliers based on quality, cost, and delivery performance.
• Conduct supplier audits and oversee compliance with ISO 9001, ISO 13485, 21 CFR 820, and MDSAP standards.
• Negotiate and enforce supplier quality agreements and manage risk evaluations.
• Lead investigations into supplier defects, issue corrective action requests (SCARs), and drive continuous improvements.
• Review engineering change orders (ECOs) and supplier manufacturing processes for manufacturability.
• Manage purchased part qualification activities (PPAP, FAIRs) and set up incoming inspection plans.

Qualifications:

• Bachelor’s Degree in Engineering (Electrical, Industrial, Manufacturing, Mechanical, or Quality).
• 5+ years’ experience in supplier quality within a regulated manufacturing environment.
• Strong analytical, problem-solving, and communication skills.
• Ability to travel 5-20%, including to domestic and international suppliers.
• Preferred: Supplier management experience, lead auditor certification, and ERP system proficiency (SAP, MasterControl).