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Quality Auditor

Quality Auditor

Life Science PeopleNetherlands, Netherlands
30+ dagen geleden
Functieomschrijving

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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    Auditor • Netherlands, Netherlands