Are you familiar with the regulations for medical devices, such as the new EU MDR? And do you know how to inspire our engineers with your quality mindset? Then we might be looking for you!
As a QA/RA Engineer you play a key role in the development and certification of our medical devices. You know how to communicate with the engineers and inspire them to work with a quality mindset. At the same time, you are always up-to-date with the latest developments in Regulatory Affairs (RA) and are able to translate that knowledge to our innovative projects. These projects are incredibly diverse, but do require a focus on quality at all times.
In the position of QA/RA Engineer, you are part of our multidisciplinary project teams in which you contribute to the development of new products. Here, you are the expert on medical regulatory affairs and product certification. At the same time, you are responsible for Quality Assurance in our projects. This implies that you ensure product safety as well as a correct way of working within our quality management systems. Also, you complete the technical file for our products in accordance with e.g. ISO13485 and the new EU MDR. Finally, you interact with our customers on a regular basis on QA/RA.
In order to fulfil the position of QA/RA Engineer, it is important that you can communicate on technical affairs with our engineers. This requires a completed technical education, preferably on University level. In addition, you meet the following requirements:
- At least 4 years of experience in Regulatory Affairs and/or Quality Assurance, of which at least 2 years in medical devices;
- Knowledge of quality management systems in medical devices, such as ISO13485 and the new EU MDR;
- You are a team player and able to inspire a team towards a common goal.
Many possibilities regarding personal development through our wide internal and external course offer. We welcome your own initiative, and give you space to do so. Accordingly, this also includes a competitive salary and flexible terms of employment.
Thanks to our engaged colleagues, communication lines are short and the atmosphere is open and informal. There are many friendly encounters, both in- and outside of work. We have an active staff association that organizes several activities throughout the year.
How to apply?
If you have any question regarding this career opportunity, please contact Koen Gruitrooij, Manager QA/RA, tel. 088-115 20 00
If you are interested in this challenging position, do not hesitate to apply. Please send your application to firstname.lastname@example.org.