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