Senior Quality Assurance Scientist
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At a glance
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Job overview
Beckman Coulter, Inc. is hiring a Senior Quality Assurance Scientist. The Senior Quality Assurance Scientist leads design and development of existing and new products at Beckman Coulter, ensuring high quality, reliability, and regulatory compliance from initiation through market release while collaborating with cross‑functional teams and applying Danaher Business System tools.
Key focus areas include Lead design and development of products from initiation through market release, Fulfill Development QA role on Assay or Systems Development Core or Design Change Teams, and Ensure documented evidence of compliance to Beckman Quality System and regulatory requirements.
Successful candidates bring Bachelor's Degree In Biochemistry, Immunology, Engineering Or Related Technical Field Or Master's Degree In Biochemistry, Immunology, Engineering Or Related Technical Field, 5 Years As Quality Engineer, Mechanical Engineer, Or Related Role With Bachelor's Degree, and 2 Years Design Assurance Experience Supporting Assay Or Systems Development Projects. Important skills include Design Assurance, Quality Systems, Design Control, DHF Compliance, Design Change, and Risk Management.
Skills & qualifications
Skills
Qualifications
Full job description
Job Duties
Senior Quality Assurance Scientist for Beckman Coulter, Inc. in Chaska, MN, to lead design and development of existing and new products from initiation through market release with an objective to provide high quality, reliable, and compliant products to market. Fulfill the Development QA role on Assay or Systems Development Core or Design Change Teams as the design progresses through the development process. Understand the product design/process reliability and ensure the creation of documented evidence of compliance to Beckman Quality System and applicable regulatory requirements. Collaborate effectively with other functional group Core Team or Change Team members in defining performance requirements, conducting risk analysis, and verification test plan execution. Drive to achieve Design for Reliability and Manufacturing results by effective use of applicable Danaher Business System tools. Ensure that assigned tasks are compliant to Beckman applicable procedural requirements as well as to FDA QSR, ISO, and other global regulations. 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 the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.
Requires: Bachelor’s degree in Biochemistry, Immunology, Engineering or related technical field (willing to accept foreign equivalent) plus five (5) years of experience as a Quality Engineer, Mechanical Engineer, or related role or, alternatively, a master’s degree in Biochemistry, Immunology, Engineering or related technical field (willing to accept foreign equivalent) and three (3) years of experience as a Quality Engineer, Mechanical Engineer, or related role. Experience must include: Two (2) years of Design Assurance (QA) experience supporting assay or systems (hardware/software) development projects in Quality Systems (Design Control) and Quality Design Assurance (DHF Compliance); One (1) year of experience on a cross-functional team or managing projects involving multiple tasks in the design and development of existing and new products; Design control processes, including design change, risk management, design requirements, design V&V, and design transfer; Risk Management; Design History File Maintenance; and Experience in other Quality disciplines (Supplier, Manufacturing, Design, Post-market Surveillance, Quality Systems, and Quality Control). Salary Range: $83,000–$145,500/year. Salary:$124,467/year. Benefits: mydanaherbenefits.com. Submit resume to [email protected]. & reference job title.
Minimum Education Required
Bachelor’s degree in Biochemistry, Immunology, Engineering or related technical field (willing to accept foreign equivalent). Alternatively, a master’s degree in Biochemistry, Immunology, Engineering or related technical field (willing to accept foreign equivalent).
Minimum Experience Required
With Bachelor's: five (5) years of experience as a Quality Engineer, Mechanical Engineer, or related role.
With Master's: three (3) years of experience as a Quality Engineer, Mechanical Engineer, or related role.
Shift
First (Day)
Number of Openings
1
Compensation
$83,000.00 - $145,500.00 / Annually
Postal Code
55318
Job Type
Full Time
Place of Work
On-site
Requisition ID
Job Benefits
mydanaherbenefits.com
Application Email
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