Quality Engineering Senior

Job Description

Job Description Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System which makes everything possible.

The **Senior Supplier Quality Engineer **for Beckman Coulter Diagnostics is responsible for ensuring the business is compliant to the Quality Management System and the Regulations.

This position is part of the Instrument Quality organization located in** Chaska, MN, **and will be * on-site *. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Instrument Supplier Quality organization and report to the Sr. Quality Manager responsible for Instrument Quality. If you thrive in a cross-functional and collaborative environment and want to work to build world-class medical devices —read on!

In this role, you will have the opportunity to:

Plans and organizes both routine and non-routine tasks such as Supplier Selections and Qualifications, Change Notifications, Audits, Corrective Actions and Supplier Scorecards

Develop supplier material control plans as part of product qualification

Primary supplier quality representative for root cause and corrective action analysis regarding supplier caused manufacturing issues

Visit suppliers to resolve product performance concerns

Recommend appropriate field actions to product regulatory committee

Lead Kaizen events to improve transactional processes, reduce variations, implement lean processes, and eliminate waste to enhance production efficiency and associate engagement.

The essential requirements of the job include:

• **Scientific degree **in a relevant field (Mechanical, Electrical, Chemical, etc.)
• 5+ years quality experience with a bachelor's degree, 3+ years with a master's degree Doctoral degree.

It would be a plus if you also possess previous experience in:

Certified Quality Engineering certification preferred.

Experience with **21CFR820 **and ISO14971