Manager QA-RA

Quality & HSE
Lead / senior
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For Demcon production and Demcon metal injection moulding in Enschede we are looking for a hands-on manager quality assurance and regulatory affairs (QA/RA) with experience in a highly regulated industrial environment. You will be involved in maintaining the quality management system and in regulatory compliance activities. Are you looking for an high-tech work environment? Then continue reading! 

About Demcon

As Demcon we are working on technological solutions to social challenges. We do this by developing, manufacturing and supplying high-quality technology and innovative products.

Within the Demcon group you will be working for:
Demcon production, specialized in the industrialization and assembly of complex mechatronic products and systems for demanding markets such as medical and high-tech systems.
Demcon metal injection moulding, specialized in metal injection moulding, a modern production technique that offers great potential for the design and production of complex, metal parts.

Both companies are located in Enschede.

As manager QA/RA you lead a team of 4 quality lead engineers within Demcon production and have a functional line to the quality lead engineer within Demcon metal injection moulding. You will report directly to the managing director with a functional reporting line towards the manager corporate QA/RA.

What are you going to do?

  • Primary representative, externally and internally, for all matters related to quality assurance and regulatory affairs;
    – compliance with certification and regulatory requirements as well as relevant internal group policies and procedures;
    – that the quality management system, procedures and templates are efficient and supportive to the business objectives;
    – activities undertaken are in accordance with corporate HSE policy and practices;
  • Negotiate and implement customer quality agreements;
  • Supervise external audits, conduct internal audits and assist in supplier audits;
  • Monitor the CAPA and complaint process, ensuring closure within agreed time scales;
  • Coach, guide and encourage your employees in their personal growth and development;
  • Promote a quality culture. 

What do you bring to the table?

  • Bachelor degree in a technical direction; 
  • Minimum 3 years of relevant QA/RA experience in a production environment in combination with new product introduction. Preferably in a managerial position; 
  • Experienced with ISO 9001 with good knowledge of medical devices quality assurance (ISO 13485) and relevant standards; 
  • Decisive and confident leader. Persuasive and able to influence effectively; 
  • Critical thinking and analytical/problem-solving skills, with a keen eye for detail; 
  • Excellent interpersonal skills. Team player. Focussed on team and personal development;
  • Good communication skills in Dutch and English, written and spoken.

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;
  • 40 days off and 8% vacation allowance;
  • A good pension scheme with PME;
  • 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 Marcel Damen (managing director) of Laure Barts (HR business partner) at 088 – 115 20 00. 

Are you interested in the position of manager QA/RA? Then we look forward to receiving your cv. You can apply via the application button.

Acquisition based on this advertisement is not appreciated.

"bringing ambitious challenges to a success together."

application procedure.

Does this vacancy appeal to you and are you curious about the application process? This goes as follows:

1. Apply
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.
5. Offer
We both see the match! Let’s make you a suitable proposal.
6. Contract
Your response to the offer is positive. We are going to finalize the collaboration!