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40 uur - GTX medical

Quality Engineer

Vacature details

Full-time

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
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