Do you have Quality and Regulatory Affairs (RA) experience in the field of development and certification of active medical products and/or in vitro diagnostic medical products? And would you like to work in a dynamic environment with a wide variety of products? Then we are looking for you!
QA/RA engineer at Demcon is a challenging position with very diverse work. You work closely with all disciplines within Demcon, but also have contact with external parties. We are looking for someone with a few years of experience in the RA profession in the field of development and certification of active medical products and/or medical products for in vitro diagnostics.
Our companies each distinguish themselves in their own field with unique expertise and skills. In doing so, they help clients to perform better and achieve more. From a passion for technology, our companies are able to join forces. By sharing knowledge and working together we make more social impact. Demcon advanced mechatronics is a multidisciplinary development and engineering partner for mechatronic challenges, from concept to realization.
What are you going to do?
As a QA/RA engineer you will be part of the quality team at Demcon’s development company in Enschede. The QA/RA engineer is part of the multidisciplinary project team. Within this team you are the point of contact in the RA area of active medical products and/or medical products for in vitro diagnostics. Your activities will be related to the development and certification of active medical products and/or medical products for in vitro diagnostics.
As QA/RA engineer your challenge is to ensure product safety and proper practices in line with our quality system. Within the development projects you are responsible for product safety and to determine which laws and regulations apply and coordinate these matters with the customer. For certification you bring the technical file in order.
What do you bring to the table?
- Biomedical technology, engineering medicine, health sciences or a technical education. (wo working and thinking level)
- At least 2 years of experience in the RA profession in the field of development and certification of active medical products and/or medical products for in vitro diagnostics
- Analytical skills and you understand the language of the engineers
- You are a team player, who can communicate and interact well at various levels both towards project team and client
- You are accurate, persuasive and pragmatic
What do we offer you?
At Demcon we value a nice workplace. For example, we have good coffee and there is free fresh fruit waiting for you every week. There is also a lot of personal attention and we discourage overtime because we know how important home is.
Furthermore, you can count on, among other things:
- A good, market-based salary
- 31 days off and 8% vacation allowance
- A good pension plan at Zwitserleven
- The opportunity to follow training and courses through the Demcon Academy so you can further develop your knowledge
- A laptop and telephone from work
- Bicycle plan
- Active personnel association (monthly activities such as drinks and an annual Demcon weekend) and annual sporting events
Do you have any questions about this position?
Do you have any questions about this position? We will be happy to answer them. Call to Milou ten Hove, manager QA/RA or Marleen Blanckenborg, corporate recruiter at +31 (0)88 115 – 20 00.
Have we aroused your interest for the position of QA/RA engineer? Then we look forward to receiving your cv. You can apply via the application button.
Acquisition based on this advertisement is not appreciated.
Does this vacancy appeal to you and are you curious about the application process? This goes as follows:
You have applied! We will discuss it internally and respond as soon as possible.
2. Phone call
We got acquainted briefly and want to get to know each other better.
3. First call
See if there is a match from both sides and if the expectations are correct.
4. Second call
We investigate a possible collaboration more closely.
We both see the match! Let’s make you a suitable proposal.
Your response to the offer is positive. We are going to finalize the collaboration!