Vacancy QA/RA Manager – Haaksbergen
9 SEP ’22: For a medical devices start-up based in Haaksbergen we are currently looking for a QA/RA Manager. This start-up offers an online platform for medical decision support. This organisation supports (medical) decision-making and diagnosing patients on a daily basis with a library of thousands of algorithms that can be used as medical tools by healthcare providers worldwide.
In this role, you will be mainly responsible for continuous improvement and maintaining the QMS and ISMS in the context of our medical tools. You support management and clinical experts in the process of development, documentation and certification of new medical tools. Furthermore:
- You keep an eye on the state-of-the-art in terms of relevant standards and legislation;
- You take care of the communication with notified bodies and other partners. Where necessary, you are able to involve external experts;
- You will be part of a team with other QA/RA engineers, (technical) physicians, biomedical technologists, health scientists, and software developers;
We are looking for someone who is open to working in a start-up environment and has a hands-on mentality. You have demonstrable experience in working with existing legislation and regulations regarding medical devices (MDD, MDR, IVDD, IVDR, ISO1348, etc.) or are willing to follow the necessary courses for this. In addition:
- You are demonstrably experienced with the process and implementation or (certification) audits by controlling authorities;
- You have a great sense of responsibility for the implementation and constant improvement of the quality policy throughout the organisation;
- You have solid English written and verbal skills. Dutch would be a plus.
Working for this start-up means a full-time job in a very nice organisation with a small team of very motivated colleagues. There is an open and pleasant working atmosphere where fun is paramount. Furthermore you:
- Work on products with impact;
- Earn a good salary with the opportunity to grow with the company;
- Get the space and opportunities to develop and improve;
- Employment type: Full-time, indefinite.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Senior Associate | Medical Devices
+31 6 12 43 13 59