Qualification and Validation Engineer - Medical Devices

Vertragsart:
Vor Ort
Start:
26.09.2016
Dauer:
6 weeks
Von:
Experis AG
Ort:
Solothurn
Eingestellt:
17.09.2016
Land:
flag_no Schweiz
Projekt-ID:
1204791

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Qualification and Validation Engineer - Medical Devices - Hägendorf

Looking for a new project within an international environment?

Then we may have the right job for you!

On behalf of our client, one of the biggest players based in Hagendorf we are looking for a Qualification and Validation Engineer within experience in a medical devices environment. This is a contracting position, starting at the end of septemberuntil the end of October with extension possibilities.
In this position as a Qualification and Validation Engineer you will be in charge of all the below validation activities:

- Equipment:

  • Functional Risk Assessment
  • Test Scripts
  • Test Report
  • Residual Risk Assessment
  • Traceability Matrix
  • Compliance Report

- FDM Script:

  • User Requirement Specification
  • Risk Assessment Typ 1
  • Compliance Plan
  • Technical Specification
  • Design Specification
  • Module Specification
  • Functional Risk Assessment
  • Hardware Qualification Table
  • Test Plan
  • Source Code Review
  • Test Script(s)
  • Test Report
  • Residual Risk Assessment
  • Traceability Matrix
  • Compliance Report

Your skills/experiences are:

  • Minimum of 2 year's experience in validation including the system development life cycle and Regulatory expectations
  • Minimum of 5 year's experience of CSV in a FDA regulated environment
  • High understanding of GMP and compiance
  • Experienced within the norms 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
  • Experienced in change management
  • Very good communication skills in German and English

If you are a result oriented Qualification and Validation Engineer currently looking for a challenging new position that applies to your skills, then we look forward to receive your application!

I'm always looking for skilled Qualification and Validation Engineer so please don't hesitate to send me your CV.