Senior Quality Engineer

3 weeks ago

Chaska, United States Beckman Coulter Diagnostics Full time

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

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 with future hybrid opportunity. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Instrument Quality organization and report to the 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:

  • 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.

The essential requirements of the job include:

  • Engineering degree in a relevant field (i.e. Mechanical, Electrical, Chemical, etc.)
    • Bachelor’s degree in field with 5+years exp. OR
    • Master’s degree in field with 3+ years exp. OR
    • Doctoral degree in field with 0-2 years exp
  • Experience applying Design Controls and Design Changes according to 21CFR820 to moderately complex design changes.
  • Experience applying Risk Management ISO14971 for Medical Device companies.

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

  • Certified Quality Engineering certification preferred.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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