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Job ID :
33282BR
Location :
Germany - Freiburg
:
Job Description
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer.

We are the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.


Quality Manager (f/m)
Job ID: 2015-DEFRE-ABR-0028
Location: Freiburg im Breisgau


Responsibilities:
  • Drive the CAPA-process, Non-Conformity Handling and Out-of-Specification processes according ISO 13485 and also ISO 14971 requirements
  • Implement and support Risk Management and Complaint Handling activities
  • Implement EDMS Solution as replacement of a paper-based CAPA system
  • Establish Quality Dashboard / Key Performance Indicators to monitor measures/actions and CIP processe
  • Interface for CAPA-Product Care activities, coordinating and monitoring compliance activities
  • Head of CAPA-Board; control all CAPA, NC and OOS activities during the whole Product Lifecycle for Freiburg
  • Project Lead to establish Electronic Data Management System for CAPA, NC and OOS process (Short -/Mid-Term Solution)
  • Project Lead for implementing MasterControl System, as required by ThermoFisher (Long-Term Solution)
  • Bridge Person to Risk Management and PPI activities
  • Subject Matter Expert for the Freiburg site for CAPA, Non-Conformity and Out-of-Specification processes
Qualifications:
  • University degree/certificate or Master (health science, biology, biochemistry area)
  • Fluent English (written and spoken)
  • 3-5 year experience in GMP business, preferred Diagnostics or Medical Devices
  • Experience in IT applications, preferred EDM-Systems and Excel
  • Experiences with CAPA and Continuous Improvement Processes, 8-D Problem solving and Risk Management according ISO 14971
  • Potential for manager position in 1-3 years

We offer:
  • Employment with an innovative, growth-oriented organization
  • Outstanding career and development prospects
  • Company pension scheme and other fringe benefits
  • Exciting company culture which stands for integrity, intensity, involvement and innovation.

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to
our singular mission.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex,
sexual orientation, gender identity, national origin, disability or any other legally protected status.

Interested?
We are looking forward to receive your application. Please refer to the above Job ID and include your salary expectations as
well as your period of notice.



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