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Consultant for Review Design History Files (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Design, Consultant
Projektbeschreibung
301967/1
IHRE AUFGABEN:
-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.
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:
Safety officer
Projektdetails
- Einsatzort:
-
Projektbeginn:
asap
-
Projektdauer:
8 MM
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Organisation/Management