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Danaher - Indianapolis, IN
posted about 2 months ago
Full-time - Senior
Indianapolis, IN
1,001-5,000 employees
Computer and Electronic Product Manufacturing
About the position
The Senior Quality Assurance Engineer at Beckman Coulter Life Sciences plays a crucial role in ensuring the quality and compliance of life science products throughout their development lifecycle. This position involves collaborating with product development and sustaining engineering teams to apply quality systems and design control processes effectively, ensuring that products meet industry standards and regulations.
Responsibilities
- Representing quality assurance on development teams and quality systems for product improvement projects.
- Coaching teams on the application of ISO 9001/13485/cGMP and quality systems processes throughout the product lifecycle.
- Partnering cross-functionally to ensure product and service conformance, focusing on Design Controls, Document Controls, Risk Management, Production, and Service Controls.
- Assuring compliant process and product documentation, including Design History, Product, Process, and Service documentation in support of product realization and commercialization.
- Influencing the interpretation of internal policies and procedures to ensure quality and compliance with current industry standards and regulations.
Requirements
- Degree in biology, chemistry, chemical engineering or related field; or equivalent experience required.
- BS+5 or MS+3 years' experience in product development, manufacturing, and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, or related life sciences industries.
Nice-to-haves
- 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 in reagent product development and manufacturing.
Benefits
- Equal opportunity employment
- Reasonable accommodation for individuals with disabilities
