Senior Quality Engineer

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 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 primarily on-site. You will be a part of the Instrument Quality organization and report to the Quality manager responsible for Instrument Quality.

In this role, you will have the opportunity to:

• Conduct comprehensive reviews of the manufacturing SOPs (standard operating procedures), document change orders, bill of materials, service manuals, part drawings, material specification sheets, field service manuals, nonconformance records, CAPAs (corrective and preventive actions) and other quality records to ensure that they are compliant with requirements of the Quality System and the regulations.
• Lead Kaizen events aimed at improving the transactional process, reduce process variations, and to implement lean processes in the production floor to reduce cycle time, maximize resource utilization, improve the experience and engagement of the production associates, and eliminate lean wastes such as correction, overproduction, motion, material movement, waiting, inventory, and process.
• Reduce instrument defects by investing/evaluating the issues identified and implementing countermeasures to prevent recurrence.
• Reduce Nonconformances by investing/evaluating the issues identified and implementing countermeasures to prevent recurrence.
• Assess the risk associated with: (i). design changes; (ii). Internal product non-conformances, (iii). External post-launch issues (iv). Systemic issues of the Quality system or instrument manufacturing business.

• Engineering degree in a relevant field (i.e. Mechanical, Electrical, Chemical, etc.)
• Bachelor’s degree in field with 5+years exp.
• Master’s degree in field with 3+ years exp.
• Doctoral degree in field with 0-2 years exp.
• Experience applying Design Controls and Design Changes according to 21
  
  CFR
  820 to moderately complex design changes.
• Experience applying Risk Management ISO
  14971 for Medical Device companies.
• It would be a plus if you also possess previous experience in:
  Certified Quality Engineering certification preferred.

Beckman Coulter…