Process Validation Engineer (maternity leave)

Are you a highly skilled Engineer who is dreaming of a job with a real impact on patients ’lives?

Do you want to work for an innovative specialist spinal implant company and play a crucial role in ensuring efficiency of our manufacturing processes?

Are you interested in a short-term contract (6 months)?

                      If yes, come to join our Process Validation team for a maternity leave replacement!

Together we can shape the future of the healthcare.

 

Your main responsibilities will be:

 

  • Writing protocols, tests sheet and qualification-validation reports.
  • Performing / overseeing the qualification/validation tests.
  • Identifying the issues, providing solutions and tests corrections.
  • Participating in the Non-Conformance resolution, Complaints and CAPA
  • Participating in the sub-contractor’s qualification (documentation, technical visit, and audit)
  • Supporting R&D: critical dimensions, inspection sheet, quality documentation
  • Writing technical documentation
  • Proposing action plan and test strategy

 

Your profile:

 

  • Proben experience in Validation /Qualification Process
  • Knowledge of machining and associated processes
  • Experience within medical device industry or spine surgery would be an advantage
  • Solid understanding of regulatory requirements, as ISO 13485
  • Higher qualification in Engineering, preferably in Mechanical
  • Strong communication Skills, with the ability to effectively convey technical information to diverse audiences
  • Good writing skills (structured documentation such as protocols and reports)
  • Able to work in English, french equivalent to mother tongue
  • Driving Licence
  • Available on February/ March for 6 months

please send your cv to careers@spineart.com