Quality and Regulatory Analyst

4 tygodni temu

Warszawa, Mazovia, Polska Danaher Pełny etat

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 Quality Assurance Regulatory Affairs Analyst for Beckman Coulter Diagnostics is responsible for QRA processes support for all EE countries (PL, CZ, SK, HU and CRO). This position is part of the Department of Quality and Regulatory located in 4 EE countries and will be Hybrid.

You will be responsible for sustain and continually improve the quality processes needed to support the Commercial Quality organization and the ISO 9001 Certification to ensure compliance and business continuity within Beckman Coulter. You should be ideally located in commuting distance from Warsaw, PL or Prague, CZ.

We are looking for a reliable and accurate team player, who will take the responsibility for delegated tasks. A self-motivated and flexible person who is willing to travel At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Department of Quality and Regulatory and report to the QRA Manager for EE. If you thrive in a fast-paced role and want to work to build a world-class QRA organization—read on.

In this role, you will have the opportunity to:

  • Coordinate the completion of Internal Audits and Sales Channel Partner (SCP) audits.
  • Perform audits to support the local entity and other EE entities as required.
  • Drive the Corrective and Preventive Action Process.
  • Support local QMS meetings and support the main Multisite QSMR by providing the required local input to the meeting.
  • Provide quality awareness trainings.
  • Representing EE QRA Team on Global Projects and coordinating process improvement implementation in EE.
  • Implement Visual Management activities including updating Daily Management boards and Monthly Performance Bowlers.

The essential requirements of the job include:

  • Degree in Chemistry or similar discipline with 1+ year experience in Quality Assurance.
  • Lead auditor certificate ISO9001
  • Proficiency in both written and spoken English and Polish or Czech required.
  • Computer skills in MS Office.

It would be a plus if you also possess:

  • Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements.
  • Ability to recognize and solve typical problems that can occur in own work area.
  • Experience in regulatory affairs - IVD market
  • Auditor certificate - ISO13485

This is a fixed-term role for 16 months.

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

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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