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.
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.
• 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.