Quality Auditor

3 weken geleden


Amsterdam, Noord-Holland, Nederland Life Science People Voltijd

Position: Medical Device - Lead Auditor

Type: Permanent

Role Overview

A Notified Body in the Netherlands are rapidly expanding their Audit teams as a result of a large project acquisition. This Notified Body has numerous subsidiaries across Europe and offers world renowned, fully funded training programs to attain all of the necessary Certificates.

Key Responsibilities

·Conduct customer audits in accordance with EU requirements and designations

·Creation of customer evaluation forms/audit reports

·Customer interaction and business development responsibilities

·Continuously up to date with current MDD/MDR 2017/745 or IVDR 2017/746 requirements

·Conformity assessment of MDR/IVDR of medical devices

·Customer complaint management

Essential Criteria

·Successfully completed Scientific or Engineering degree (BSc/Msc)

·4+ years' experience within Medical Device Industry (existing Notified Body experience preferred)

·2+ years' within Research & Development, Quality, Regulatory for Active and / or Non-Active

·Knowledge of working under and/or implementing systems related to MDR (2017/745)

·Internal/External Audit experience (preferred)

·Fluent in English and professional knowledge of Dutch

·Excellent verbal and communication skills

Benefits

·Work for a Leading Notified Body

·Excellent fully funded training programs

.Regular salary reviews once onboarded


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