QM scientist - (M/F)

 

Your responsibilities:

 

  • Review and approve documentation for compliance with EU, and other international regulations
  • Identify and manage areas of potential noncompliance (Process quality deviations CAPAS)
  • Monitoring and further development of the QM System according to ISO 13485 and regulatory requirements in accordance with the IVD guidelines.
  • Work as a member in the quality management and quality control department.

 

Your profile:

 

  • Minimum Bsc. in scientific discipline
  • Good understanding and knowledge of ISO 13485:2016, ISO 14971, IVDD 98/79/CE, Canadian regulations, FDA regulations, (other regulations would be considered as a plus)
  • Experience in RT-PCR is an asset
  • Good knowledge of MS office
  • Fluent in English both writing and speaking, any other language is considered as an advantage
  • Communication in a clear, concise and timely manner
  • Very well organized, including attention to detail, but flexible in thinking
  • Ability to stick to timetables and work under pressure.

 

The position will be based in Luxembourg.

 

If you feel that our job profile matches your qualifications and personality, please do not hesitate and send us your application in English, including resume, covering letter and your expected salary, by post or e-mail to the following address:

 

Fast Track Diagnostics Luxembourg SARL

Ms. Elisabeth CHACTOURA

29, rue Henri Koch- L-4354/ Esch s/ Alzette

e-mail: Elisabeth.Chactoura@fast-trackdiagnostics.com