Quality Assurance Engineer

Staff Quality Assurance Engineer or Scientist

Onsite role located in Indianapolis, IN or Loveland, CO.

• Representing quality assurance on development teams, quality systems and product improvement projects for Beckman Coulter Life Science.
• Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout product lifecycle.
• Partnering cross functionally to ensure product and service conformance with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls.
• Assuring compliant process and product documentation, inclusive of Design History, Product, Process and Service documentation in support of product realization and commercialization within the Beckman Coulter quality system.
• Awareness of current industry standards and regulations and how they relate to internal policies and procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance.

• Degree in engineering or other science or related field; or equivalent experience required.
• BS+7 or MS+4 years’ experience in product development, manufacturing and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries.

• Ability to identify, develop and execute quality system, product and process improvements. Driving change cross functionally across multi-site operations.
• Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired.
• Experience with product software development lifecycle management.

Beckman Coulter Life Sciences, 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.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of 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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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or