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Medical devices

Qualification Engineer

Context

  •  

    Location

    France
  • Start date

    From the 06 April 2020

Ideal profile

  • Educational background

    Master degree in the field of health or biomedical sciences.

  • Experience

    • Successful experience of at least 2 years in equipment qualification / validation activities in the pharmaceutical or medical device industry.Successful experience of at least 2 years in equipment qualification / validation activities in the pharmaceutical or medical device industry.
    • You know and master all or part of the GMP (or GMP), ISO 13 485 and ISO 11 607 standards as well as the FDA requirements for the manufacture and control of medical devices.

Proposed project

  • Attached to the Quality department, you act as the guarantor of the good conduct of the qualification / validation of equipment and processes.
  • At different phases of the project (Audit, APS, APD, Tender, Monitoring, Commissioning / Qualification), you bring technical solutions in compliance with the applicable standards in force.
  • You evaluate the regulatory approach of a validation project (FDA, GMP) in terms of Equipment, Processes and Utilities.
  • You define and then implement Master Plans for Qualification / Validation (Validation Master Plan).
  • You are arguing your Qualification Policy with your contracted customers / suppliers.
  • In addition, you identify and justify the critical points to check through criticality analysis tools, and ensure project coordination on the qualification and validation part in the execution phase.
  • You perform document management related to qualifications (Writing, Approval, Execution protocols, reports), plan and monitor qualification activities. Through this technical work, you also evolve in project management, or quality, planning and budget monitoring.

The different steps to integrate the tribe

  • First interview with the HR team
  • Technical interview with a Business Engineer
  • Physical meeting in our office and constitution of the skills file
  • Last exchange with one of our leaders

Apply for this position

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