Senior Quality Assurance Scientist

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

The Senior Quality Scientist role for Beckman Coulter Diagnostics is responsible for providing leadership as the Development Quality functional core team member in the 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. You’ll drive to achieve products that comply with design controls by using the Danaher Business System tools. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

This position is part of the Quality team located in Sacramento and will be on-site At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

In this role, you will be part of the Diagnostics Development Quality team, reporting to the Manager for Development Quality Assurance. Our goal is to provide high quality, reliable, cost competitive, and regulatory compliant products to market. The Development Quality team exists to ensure our new and improved products are developed in a compliant manner and provided to our customers with the utmost quality to advance healthcare for every patient. If you thrive in a face-paced and diverse role, and want to work to build a world-class Quality organization—read on!

In this role, you will have the opportunity to:

• 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 task 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.

The essential requirements of the job include:

• Bachelors degree in Biochemistry, Immunology, Engineering or related technical field preferred with minimum of 5+ years of experience or Master’s degree in field with minimum of 3+ years of experience, or Doctoral degree with 0-2 years of experience
• 2 or more years of Design Assurance (QA) supporting assay or hardware/software development projects in Quality Systems (Design Control) and Quality Design Assurance (DHF Compliance)
• 1 or more years of experience on cross-functional team and/or managing projects involving multiple tasks.
• Demonstrated knowledge of design control processes, including design change, risk management, design requirements, design V&V, and design transfer.
• Proficient in word processing, spreadsheets, MS PowerPoint, and project management skills

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

• Practical experience in other Quality disciplines (Supplier, Manufacturing, Design, Post-market Surveillance, Quality Systems, and Quality Control).
• Ability to influence decisions within Dev QA function and across functions within product line or project.
• Ability to support several projects simultaneously while effectively adapting to changing project parameters.

The salary range for this role is between $90,000 - $120,000. 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. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits 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.

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