Keywords: structure, customer-oriented, initiative, responsibility, passion for compliance, curious
Holland Innovative’s Medtech team specializes in supporting companies in the development & production of medical devices in accordance with the Medical Device Regulation (MDR) and/or the In Vitro Diagnostic Regulation (IVDR). The goal of our team is to excel in launching new and reliable innovations that contribute to the quality of life. We strengthen the project teams of clients with competencies such as project management, quality assurance, regulatory affairs and Design for Six Sigma methodologies. Because of our integrated and pragmatic approach, we are distinctive in the market. A good example of this is our new training Fundamentals in Medical Device Development, in which we share our knowledge on how to build a safe medical device, within time and budget.
As a QA-RA specialist, you help the customer with what they need to organize the processes and documentation in the organization in such a way that the products developed are safe, work as intended and comply with applicable regulations. Because we work for many different companies, it is a very varied job. One day you work on the documentation for the production of a Corona-speed-test under the IVDR, the next day you support a team in risk analysis for innovation in the field of ultrasound.
Tasks and responsibilities
The QA/RA aspects can be combined with project management activities or for example the use of Design for Six Sigma or Reliability aspects. If you are not (yet) familiar with this, you will team up with a fellow specialist from HI in this field. That’s how we build on each other’s strengths. You bring structure, show leadership and take initiative to implement the assignment properly. Your work depends on the organization you work for, think of:
- Setting up a regulatory strategy
- Setting up a complete quality management system
- Organizing transition from MDD/IVD to MDR/IVDR
- Organizing risk management activities in accordance with ISO 14971
- Organizing validation activities for a specific product
- Setting up a complete technical file
- Setting up the post-market surveillance process
- Coaching a QA/RA manager at the customer
- Coaching Engineering teams
- Setting up and giving training
- Interim QA/RA Manager
Within Holland Innovative, specialists work in different fields and for various markets, this gives you the flexibility to work in other areas as well. This combination of projects gives you the opportunity to learn and develop yourself in a broader way.
- BSc or MSc degree in a technical discipline (biomedical technology, mechanical engineering, physics, electrical engineering, technical medicine or software development)
- At least 5 years of relevant work experience in QA/RA related work
- Experience with quality management systems
- Experience in the use of legal requirements and standards (MDD, MDR, IVD, IVDR, ISO 13485 and ISO 14971)
- Knowledge and experience in the field of In Vitro Diagnostics is an advantage
- Knowledge and experience with the FDA and/or Health Canada is an advantage
What do we offer?
- A flat organization with an open culture and extensive knowledge sharing between colleagues
- The opportunity to participate in training sessions within the HI Academy: Work with the best, learn from the best
- Varied work in various projects
- Plenty of room for personal development and an eye for employee needs
- We have offices at the High Tech Campus in Eindhoven, UT Campus in Enschede, in The Hague and in the near future also in the Amsterdam/Utrecht region.
- Opportunities to make your own dreams come true
- Good working conditions, including 28 holidays and the option to buy holidays
Interested in this vacancy? Send your motivation and CV to Eefke van Daal (firstname.lastname@example.org). Ivo Aarninkhof (06-12041714) can be contacted for questions regarding the content of the vacancy.
Acquisition as a result of this vacancy is not appreciated.