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Analyst II Quality Assurance

Beckman Coulter Diagnostics Prague, Czechia Category Quality & Regulatory Affairs Job Id R1286281 Location Prague, Czechia
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JOB DESCRIPTION

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 Analyst II Quality Assurance for Beckman Coulter Diagnostics is responsible for creation/update of products Instructions for Use, QA (Quality Assurance) validations, supplier management and investigations of nonconformities/customer complaints.

This position is part of the Quality and Regulatory Affairs (QRA) department located in Prague and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Quality and Regulatory Affairs team and report to the Quality and Regulatory Affairs Supervisor responsible for several QRA processes. If you thrive in a multifunctional, fast paced role and want to work to build a world-class organization focused on quality —read on.

In this role, you will have the opportunity to:

  • create/update Instructions for Use for our products
  • participate in the review and approval of validation documents
  • support supplier quality activities
  • investigate causes of nonconformities or customer complaints in close cooperation with the manufacturing department
  • work in a small team providing all QRA activities

The essential requirements of the job include:

  • B.Sc., M.Sc., or PhD in chemistry, biochemistry, biology or other relevant technical field
  • multiple years of experience in a Quality or other relevant functional role within a regulated industry 
  • fluent Czech, upper intermediate spoken and written English
  • flexibility in learning new issues in the areas of quality assurance and regulatory affairs
  • sense of teamwork

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

  • quality assurance systems based on EN ISO 13485
  • production of in-vitro diagnostic devices

#LI-Onsite

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.

At Danaher, 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.

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