Sr. Quality Engineer

Posted 4 Days Ago
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New Brighton, MN
In-Office
115K-125K Annually
Senior level
Healthtech • Other • Software • Biotech
The Role
The Sr. Quality Engineer ensures quality of processes/products through audits, inspections, data analysis, and improvement projects in life sciences.
Summary Generated by Built In

Bring more to life.

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

At Radiometer, 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.

At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

Learn about the Danaher Business System which makes everything possible.

The Sr. Quality Engineer is responsible for assuring the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards. In addition, driving quality related improvement projects through cross functional teamwork in the assigned Value Stream.

This position reports to the Sr. Manager, Quality Engineering and is part of the Quality Assurance and Regulatory Affairs team located in New Brighton, Minnesota and will be an on-site role.

In this role, you will have the opportunity to:

  • Lead value stream specific quality tasks, including change control, training, non-conformance, and CAPA closure.
  • Conduct quality data analysis, trending, root cause investigation, and implementation of countermeasures.
  • Work with manufacturing associates, R&D, Engineering, and other partners on projects relating to quality and reliability, including manufacturing documentation
  • Own QMS SOPs related to CAPA, production nonconformances, planned deviations and complaint investigations.
  • Utilize Danaher Business System (DBS) concepts and tools in the performance of daily activities.

The essential requirements of the job include:

  • 5+ years of manufacturing experience in an FDA regulated or ISO certified industry
  • In depth knowledge of QMS processes related to CAPA, nonconformance management, planned deviations, and complaint investigations.
  • Practical knowledge of risk management processes, statistical data analysis, and change control
  • Bachelor’s degree in engineering, sciences or relevant work experience

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

  • Up to 10% may be required including international travel

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

  • Assembly and testing of thick film sensors for use in blood gas analysis
  • Statistical Software Knowledge, JMP

Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $115K – $125K. 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 job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

#LI-LCS

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.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [email protected].

Top Skills

Fda Regulations
Iso Standards
Qms
Statistical Software
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The Company
HQ: Brea, CA
10,526 Employees
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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