Quality Assurance Scientist II
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 Quality Assurance Scientist II is responsible for Reagent Manufacturing Quality Assurance, encompassing tasks such as approvals for nonconformances 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 team l ocated in Chaska, MN and will be an on-site role. In this role, you will have the opportunity to: Provide Quality Assurance support for immunoassay medical device reagent manufacturing. Ensure compliance with corporate policies, guiding teams to prevent deviations and proactively improve processes. Collaborate cross-functionally to manage non-conforming products (identification, containment, disposition). Partner with R&D, Tech Ops, and Manufacturing to optimize product quality, reduce waste, and enhance customer satisfaction. Establish and drive daily management actions for quality processes aligned with corporate initiatives.
Requirements
- Bachelor’s degree in science or engineering with 2+ years’ experience OR Master’s degree in science or engineering with 0 years’ experience
Nice To Haves
- Experience working in Quality Assurance
- Experience working in a regulated industry
- Knowledge of FDA regulations and ISO standards
Responsibilities
- Provide Quality Assurance support for immunoassay medical device reagent manufacturing.
- Ensure compliance with corporate policies, guiding teams to prevent deviations and proactively improve processes.
- Collaborate cross-functionally to manage non-conforming products (identification, containment, disposition).
- Partner with R&D, Tech Ops, and Manufacturing to optimize product quality, reduce waste, and enhance customer satisfaction.
- Establish and drive daily management actions for quality processes aligned with corporate initiatives.
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
