Auditor / Technical Documentation Reviewer for Medical Devices

Auditor / Technical Documentation Reviewerfor Medical Devices

Role Description

This is a full-time role for an Auditor/Assessor - Global Medical Service Center (GMSC). The Auditor/Assessor will be responsible for conducting quality assurance audits, performing assessments, and ensuring compliance with relevant regulations and standards in the medical devices industry. This role will involve analyzing data, evaluating processes, and providing recommendations to improve quality management systems.

Your tasks:

Evaluation of the technical documentation (TD review) of medical devices under MDR.

Conducting audits according to MDR, ISO 13485, and MDSAP if applicable.

Assessment of changes to products and QM systems, SSCPs, PSURs, and vigilance, as part of continuous surveillance.

Preparation of audit programs and sampling plans, allocation of resources, verification of applications, classification, coding, etc.

Participation in conformity assessment procedures, especially for complex or novel medical devices.

Liaising with internal and external experts (e.g. clinical experts, risk assessors).

Support with enquiries from authorities, and participate in inspections by ZLG, DAkkS and SCC if necessary.

Support for internal improvement measures.

Mandatory Requirement in your profile:

Valid Lead auditor certificate for ISO 13485.

Completed studies in a relevant field (e.g. medical technology, biomedicine, engineering, natural sciences).

Several years of professional experience (> 4 years) in the development, manufacture, testing or quality assurance of active or non-active medical devices.

Ideally several years (>10 years) of professional experience as an auditor and/or product assessor at a Notified Body for the MDR Regulation (EU) 2017/745.

Your professional experience demonstrates a wide range of medical devices (MDA and/or MDN codes) and technologies (MDT codes).

In-depth knowledge of MDR, ISO 13485, MDSAP documents, as well as other regulatory requirements, MDCG guidelines and product standards.

Recognized and proven qualifications as Lead Auditor for MDR, ISO 13485 and ideally MDSAP.

Strong ability to assess complex technical and clinical issues.

High degree of personal responsibility, objectivity and professional communication.

Willingness to travel internationally (as required)

MDR Code Requirement:

MDA 0202- Active non-implantable imaging devices utilising non-ionizing radiation

MDA 0301- Active non implantable device using ionizing radiation

MDA 0305- Active non implantable device using ionizing radiation

MDN 1101/B- Non-active cardiovascular and vascular implants

MDN 1102/A- Non-active osteo- and orthopaedic implants - Rigid

MDN 1102/B- Non-active osteo- and orthopaedic implants - Joint

MDN 1104- Non-active soft tissue and other implants

MDN 1204- Non-active non-implantable devices for wound and skin care

MDS 1003 - Devices manufactured utilising tissues or cells of animal origin, or their derivatives