Global Lead Auditor – Full Time –


Position: Global Lead Auditor

Type: Permanent

Role Overview

A leading Notified Body is continuing to build upon their, already, globally recognised Auditing team and seeking a Medical Device Auditor. Our client employs over 18,000 experts across several sectors including: Medical Devices, Automotive, Industrial and Construction and is situated in 725 different office locations.

You will be working alongside the European Regional department to facilitate their growth in Germany throughout 2021 and preparing for several large projects in 2022.

Key Responsibilities

Conduct customer audits in accordance with EU requirements and designations
Creation of customer evaluation forms
Customer interaction and business development responsibilities
Continuously up to date with current IVDD/IVDR 2017/746 requirements
Conformity assessment of IVDR medical devices
Customer complaint management

Essential Criteria

Completed scientific degree
4+ years’ experience within Quality/Auditing for IVD Devices
Understanding of IVDD & IVDR
Certification according to ISO 13485
Fluent in English and German (preferably)
IVD background – Surgical, monitoring, ventilation etc. devices
Excellent verbal and communication skills


Within a globally recognised Notified Body organisation
Excellent fully funded training programs
Opportunities to travel across Europe
Competitive salary
Integral part of large-scale industry certification project

Salary: £70000 – £90000/annum

Job Type: Permanent

Location: Köln (50765), Nordrhein-Westfalen

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