Engineering

Freelance Quality Management Specialist

  • Location

    Heidelberg

  • Sector:

    Medical Devices

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Max Jones

  • Contact email:

    m.jones@ioassociates.eu

  • Job ref:

    BBBH159242_1746181514

  • Duration:

    6 Months

  • Startdate:

    ASAP

Freelance Quality Management Specialist (Medical Devices)
Location: South Germany | Contract | Duration: 6

Our client, an innovative medical device company based in South Germany, is seeking an experienced Quality Management Specialist on a freelance basis to support their regulatory and quality operations during a critical growth phase.

This role has arisen as part of a strategic project to launch a new medical device, requiring focused support in strengthening and aligning the Quality Management System (QMS) to meet EU MDR and ISO 13485 standards. The contractor will play a key role in ensuring all quality and compliance activities are in place ahead of market entry and notified body review.

Role Overview
As a contractor, you will work closely with the internal QA/RA team to maintain and enhance the QMS in compliance with EU MDR, ISO 13485, and relevant German national requirements (MPDG). You will help ensure that quality processes are robust and consistently applied across the product lifecycle, from development through post-market.

Key Responsibilities

  • Maintain, review, and improve the company's ISO 13485-compliant QMS

  • Support EU MDR compliance activities, including technical documentation and post-market surveillance

  • Prepare for and support internal and external audits, including Notified Body and state authority inspections

  • Manage CAPA, non-conformance, and complaint handling processes

  • Collaborate with R&D, Production, and Regulatory Affairs to ensure quality is embedded throughout

  • Provide training and guidance on quality procedures and regulatory developments

  • Act as a liaison with relevant state-level authorities when required

Candidate Profile

  • Minimum 5 years of experience in Quality Management within the medical device industry

  • Strong knowledge of ISO 13485, EU MDR, and ideally the German MPDG

  • Experience supporting or leading audits (internal and external), including Notified Body inspections

  • Able to work independently and manage tasks with minimal supervision

  • Fluent in both German and English

  • Freelance/contractor status with availability to be on-site in South Germany several days per week (hybrid working possible)

If you are interested in joining an innovating MedTech business where you can continue to have a positive impact on the industry, please don't hesitate to reach out.