Zaken doen
40 uur - GTX medical

Quality Engineer

Vacature details


As a Quality Engineer you will support the existing Quality Management System (QMS) processes that are ISO13485 certified.

Within GTX medical we are developing a Therapy with the aim to let paralyzed people walk again. As part of the Therapy we are developing an active implantable device (AIMD) that from a Quality perspective needs to comply with the MDR / FDA regulations.

Excited to work in a high-tech environment and work on a therapy that can be life-changing for paralyzed people? Check our vacancy and apply now.


Your Challenge

As a Quality Engineer you will support the existing Quality Management System (QMS) processes that are ISO13485 certified, including:

  • Execution of the daily operation of several ISO13485 quality procedures;
  • Planning and execution of internal audits, QMS training and other administrative tasks;
  • Flow creation in Process2Flow (a QMS tool) to automate QMS workflows and verification and validation of these flows;
  • External quality audit preparation, following up on audit findings;
  • Maintain control of training records.


Your Profile

• You have a bachelor’s degree in a relevant engineering discipline;

• You have relevant industry experience in medical devices and ISO quality management; preferably active implantable devices.

• You are a process-oriented finisher with a mindset to get the details right and consistent, yet in a pragmatic way not hindering development speed;

• You have experience with MDR / FDA regulations;

• You have experience as internal auditor;

• You have strong affinity with the use of Software tooling and are a fast learner on how to use them correctly;

• You are a high energy, self-motivated, pro-active individual able to work in a diverse team within a young company; you are willing to help your colleagues;

• You are fluent in English. This is our company language. Mastering of French and/or Dutch language is highly appreciated.

Vacature details
  • Medical Devices
  • Quality Management System - ISO13485
  • MDR / FDA regulations
  • Start-up environment
  • Multidisciplinary Engineering Team
Solliciteer nu

You're using an old browser
The support for your browser is limited. To enhance your internet experience it's recommended to update your browser. Update browser now!