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Consultant for Review Design History Files (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Design, Consultant

Projektbeschreibung

REFERENZNUMMER:

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

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland