Job Description

Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you’ll help drive our vision of accelerating answers—and our commitment to excellence.

Beckman Coulter Life Sciences is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Do you want to work in Beckman Coulter Life Sciences Product Development Quality? Do you enjoy working with product development and sustaining engineering teams on delivering high quality life science products? Then read on!

We are currently seeking a Senior Quality Assurance Engineer or Scientist who will be responsible for facilitating application of quality system and design control processes with teams across Beckman Coulter Life Science products supporting instrumentation, consumables and reagents.

In this role, you will be responsible for:

• 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 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.

The required qualifications for the job include:

• Degree in biology, chemistry, chemical engineering or other science 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, related life sciences or other regulated industries.

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

• 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 would be preferred, not required.

#LI-GC1

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.