Consultant for Review Design History Files (m/f)

Baden-Württemberg  ‐ Onsite
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Description


We are looking for a
Consultant for Review Design History Files (m/f)

Reference: -en
Start: 05/16
Duration: 8 MM
Place: in Baden-Württemberg
Branch: Herstellung von medizintechnischen Apparaten und Materialien a. n. g.

Your tasks:
  • Support and Review Design History Files for Conformance to applicable requirements
  • Clear Design Inputs
  • Outputs and Verification
  • Sample Sizes
  • Test Method validation.
  • Gaps versus regulations and will provide rapid resolution to gaps.





Your qualifications
  • Experience in Medical Devices.
  • Experience in design control CFR part 820.30
  • Working knowledge of Part 820 FDA Quality System
    Regulation, ISO 13485, and the Medical Device Directive.
  • Relevant experience with in Engineering, or a related discipline.
  • Must be able to work independently and as a member of a crossfunctional
    team, to multi-task and do what it takes to meet high
    expectations and tight deadlines. Will be working on highly visible
    projects in high-pressure situations.
  • Must have good written & oral communication skills and the ability
    to communicate appropriately.



Skills:
- Safety officer
Start date
05/16
Duration
8 MM
From
Hays AG
Published at
18.04.2016
Contact person:
Kerstin Werner
Project ID:
1112568
Contract type
Freelance
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