Consultant für Review Design History Files (m/w)

REFERENZNUMMER:

301967/1

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 QUALIFIKATIONEN:

-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.

WEITERE QUALIFIKATIONEN:

Sicherheitsbeauftragter