Staff Quality Assurance Scientist - Chaska

Danaher Company • Chaska, MN 55318

Posted 4 weeks ago

Job Description

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.

Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.

If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at .

Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

  • Provide design control and risk management oversight to various development projects. Serve as back up Risk Manager where required.
  • Facilitate risk assessments for new designs and design changes at various project development phases. Ensure that risk management activities are performed in accordance with company procedure
  • Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans. This includes evaluating gaps for IVDR, generating plans for addressing the gaps and ensuring successful implementation of standards/procedures to support IVDR compliance
  • Provide guidance to project teams on project specific processes and deliverables. Ensure key elements of product developments are documented in design and development plan or design change plan. Ensure Plans are established and updated timely
  • Generate and analyze customer feedback data to improve product reliability and performance for our customers that is within the scope of the project
  • Support development of concise and complete verification and validation strategies that efficiently generate bodies of objective evidence to confirm product requirements compliance and the global regulatory submission strategy. Ensure all test anomalies/deviations are investigated, cause determined, impact assessed, plan of action defined, and resolution is verified
  • Ensure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs
  • Drive continuous improvement of new product development procedures, methods, tools, techniques, and training, etc. to support project specific efficiencies.

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a pageDiversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


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