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