Senior Quality Analyst

vor 1 Monat

Starnberg, Deutschland Beckman Coulter Diagnostics Vollzeit

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.

As a Senior Quality Analyst for Beckman Coulter Diagnostics you will be responsible for Quality Management responsibilities that drive significant impact to the organization. You will report to the Senior Manager responsible for Quality Systems management.

This position is part of the Quality Systems department located in Munich, Germany with flexible, hybrid working arrangements.

If you thrive in a multifunctional environment and Quality Management role and want to work to build a world-class Quality organization—read on

In this role, you will have the opportunity to:

Quality System Management Support:

  • Support the QSMR management – planning, organization and documentation, QSMR action tracking
  • Support the External Audit Management – planning, real-time audits, post-audit activities
  • Responsible for Quality Systems topics such as, responding to audit findings, QMS document reviews

CAPA Management:

  • Responsible for CAPA activities to problem statements, root cause analysis, corrective and preventative actions, tracking of time lines, and establishing CAPA files.

  • Monitor the effectiveness of the CAPA system.

  • Support or Conduct training on tool usage SMARTSOLVE, EDMS, MasterControl

The essential requirements of the job include:

  • Bachelors or Master´s degree in Engineering / Science field
  • Over 6 years of experience in Quality Management Systems in a Pharma or Medical Device industry
  • Knowledge of ISO 13485, IVDR, 21 CFR Part 820 and 11
  • Excellent Quality Documentation skills (Good Documentation Practices)
  • Ability to work independently
  • English Mandatory, German is beneficial

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

  • Electronic Documentation Management (GxP Tools, MS office)
  • Exposure to Certification body / FDA audits

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 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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