You can't change the direction of the wind, but you can adjust your sails to always reach your destination
Over de functie
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.
We will boost your career through personal and technical growth. We’ll support you by offering a personal coaching and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies. This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the Yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!
Our client is a highly innovative company which is developing a revolutionary new medical therapy. The company culture is social, hard working and caring. They are very proud at their innovative therapy and aim it to be implemented globaly in the future.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer 06-13888330
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.