Beschreibung
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