Supplier Quality Assurance Lead - Medical Devices

Job Description

Job Description Shape reliable diagnostics, one supplier at a time

Picture a day where your decisions ripple across labs worldwide. As the Supplier Quality Assurance Lead for Beckman Coulter Diagnostics—part of Danaher’s 15+ operating companies—you translate rigorous standards into real-world impact. Every hour, more than one million tests run on our systems. That pace touches 1.2 billion patients and over three million clinicians each year. Your work helps keep that promise accurate and dependable.

Based on-site in Chaska, MN, you will join our Instrument Supplier Quality team and report to the Sr. Quality Manager, Instrument Quality. You’ll thrive in a culture where diverse viewpoints matter, continuous improvement is a habit, and innovation moves at the speed of life.

Explore how we work through the Danaher Business System.

A day in the role

You start by reviewing a change notification from a strategic component supplier, mapping potential risks, and defining verification needs. Midday, you lead a root cause analysis on a supplier-related nonconformance, aligning actions across Quality, Engineering, and Operations. In the afternoon, you host a Kaizen to streamline incoming inspection flow—reducing variation and waste while raising engagement across the team. You wrap up with a supplier scorecard review and prep recommendations for an upcoming product regulatory committee meeting.

What you will do

• Plan and manage both routine and complex activities: supplier selection and qualification, change notifications, audits, corrective actions, and supplier scorecards.
• Create supplier material control plans that support robust product qualification.
• Act as the primary supplier quality lead for root cause investigation and corrective action tied to supplier-induced manufacturing issues.
• Visit supplier sites to troubleshoot and resolve product performance concerns.
• Present and recommend appropriate field actions to the product regulatory committee.
• Lead Kaizen events to improve transactional processes, reduce variation, drive lean practices, eliminate waste, and boost production efficiency and associate engagement.

What you bring

• A scientific or engineering degree in a relevant discipline (e.g., Mechanical, Electrical, Chemical).
• 5+ years of quality experience with a bachelor’s degree; 3+ years with a master’s degree; or a doctoral degree.
• Certified Quality Engineer (CQE) preferred.
• Working knowledge of 21 CFR 820 and ISO 14971.

Why Beckman Coulter Diagnostics

For over 90 years, we have advanced the role of the diagnostic laboratory in improving patient health. Our solutions power routine and complex testing in hospitals, reference and research labs, and physician offices around the world. Join us and help reimagine healthcare—one diagnosis at a time.