Senior Quality Engineer

Job Posted 22 Days Ago Posted 22 Days Ago
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Chaska, MN
100K-130K
Senior level
Healthtech • Other • Software • Biotech
The Role
The Senior Quality Engineer ensures compliance with Quality Management Systems, leads process improvements, and resolves instrument defects while assessing risks associated with quality changes.
Summary Generated by Built In

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 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 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 manufacturing SOPs, change orders, service manuals, part drawings, and other quality records to ensure compliance with Quality System requirements and regulations.
  • Lead Kaizen events to improve transactional processes, reduce variations, implement lean processes, and eliminate waste to enhance production efficiency and associate engagement.
  • Reduce instrument defects by investigating identified issues and implementing countermeasures to prevent recurrence.
  • Reduce nonconformances by evaluating identified issues and implementing countermeasures to prevent recurrence.
  • Assess risks associated with design changes, internal product non-conformances, external post-launch issues, and systemic issues of the Quality System or instrument manufacturing business.

The essential requirements of the job include:

  • Engineering degree in a relevant field (Mechanical, Electrical, Chemical, etc.)
  • 5+ years quality experience, Master's degree with 3+ years of quality experience, or Doctoral degree.
  • Experience applying Design Controls and Design Changes
  • Demonstrated experience with CAPA and risk assessments

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

  • Certified Quality Engineering certification preferred.
  • Experience with 21CFR820 and ISO14971

The salary range for this role is 100K-130K This is the range that we, in good faith, believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

#LI-Onsite  #LI-NS3

Join our winning team today. Together, we’ll 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. 

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

Top Skills

21Cfr820
Iso14971
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The Company
HQ: Brea, CA
10,526 Employees
On-site Workplace
Year Founded: 1935

What We Do

Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

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