Beschreibung
Für unseren Kunden suchen wir einen
Consultant für Review Design History Files (m/w)
Referenz: -de
Beginn: 05/16
Dauer: 8 MM
Ort: in Baden-Württemberg
Branche: Herstellung von medizintechnischen Apparaten und Materialien a. n. g.
Ihre Aufgaben:
- The team are looking for 2 Devise History file consultants to support the project. The consultants will support and Review Design History Files for conformance to applicable requirements They will Review and Define
- Clear Design Inputs
- Outputs and Verification
- Sample Sizes
- Test Method validation.
- Gaps versus regulations and will provide rapid resolution to gaps.
Ihre Qualifikation
- 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:
- Sicherheitsbeauftragter