Quality Assurance Regulatory Affairs Specialist

1 miesiąc temu


Warszawa, Mazovia, Polska Danaher Pełny etat
Beckman Coulter Diagnostics: A Leader in Diagnostic Solutions

At Beckman Coulter Diagnostics, we are committed to advancing and optimizing the laboratory to move science and healthcare forward. Our team is dedicated to providing innovative diagnostic solutions that address the world's biggest health challenges.

About the Role

We are seeking a highly skilled Quality Assurance Regulatory Affairs Analyst to join our team. As a key member of our Department of Quality and Regulatory, you will be responsible for supporting QRA processes for all EE countries (PL, CZ, SK, HU, and CRO). This is a hybrid role, and you will be based in one of our EE countries, with the option to work remotely.

Key Responsibilities
  • Coordinate the completion of Internal Audits and Channel Partner (ECP) audits.
  • Perform audits to support the local entity and other EE entities as required.
  • Drive the Corrective and Preventive Action.
  • Support local QMS meetings and provide local input to the main Multisite QSMR.
  • Provide quality awareness trainings.
  • Implement Visual Management activities, including updating Daily Management boards and Monthly Performance Bowlers.
Requirements
  • Degree in Chemistry or a similar discipline with 1+ year of experience.
  • Proficiency in both written and spoken English and Polish or Czech required.
  • Computer skills in MS Office.
What We Offer

We offer a competitive salary and benefits package, as well as the opportunity to work with a dynamic and innovative team. If you are a motivated and flexible individual with a passion for quality and regulatory affairs, we encourage you to apply for this exciting opportunity.

At Danaher, we value diversity and the existence of similarities and differences 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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