Senior Quality Assurance Scientist
About The Position
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 Assurance Scientist is responsible for Reagent Manufacturing Quality Assurance, encompassing tasks such as approvals for nonconformances, design changes, and other quality documentation. Key responsibilities also include attending Material Review Board (MRB) meetings and providing general floor support. This position reports to the Reagent Quality Manager and is part of the Reagent Quality department located in Chaska, MN and will be an on-site role. In this role, you will have the opportunity to: Provide strategic Quality Assurance support for medical device Reagent manufacturing. Serve as an independent quality leader, guiding teams through design changes and process improvements, ensuring robust compliance (FDA QSR, ISO) and proactive non-conformance prevention. Lead and/or support cross-functional teams in advanced non-conforming product management, driving systemic corrective actions. Partner with R&D, Technical Operations, and Manufacturing to optimize product quality, reduce waste, and enhance customer satisfaction. Apply Danaher Business System tools to make continuous improvements across the business.
Requirements
- Bachelor’s degree in a relevant field with 5+ years of experience, OR Master’s degree in a relevant field with 3+ years of experience, OR Doctoral degree in a relevant field
- Experience with design change processes in a regulated environment
- Knowledge of FDA regulations and ISO standards
Nice To Haves
- Experience in IVD Medical device or Pharmaceutical Manufacturing
- Experience working in Quality Assurance
- Experience with Risk Management
Responsibilities
- Provide strategic Quality Assurance support for medical device Reagent manufacturing.
- Serve as an independent quality leader, guiding teams through design changes and process improvements, ensuring robust compliance (FDA QSR, ISO) and proactive non-conformance prevention.
- Lead and/or support cross-functional teams in advanced non-conforming product management, driving systemic corrective actions.
- Partner with R&D, Technical Operations, and Manufacturing to optimize product quality, reduce waste, and enhance customer satisfaction.
- Apply Danaher Business System tools to make continuous improvements across the business.
Benefits
- Beckman Coulter Diagnostics, 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 .
- We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
