Vacancy QA/RA Specialist – Muiden
21 OCT ’21: For an organisation, that specialises in the development of over-the-counter medical devices and health products, we’re looking for a QA/RA Specialist. This organisation operates under the quality standard ISO 13485 and provides a high-quality self-care range of products within a short period with the purpose to enhance people’s lives. Are you familiar with the MDR requirements and do you want to make an impact in the organisation? Then this might be something for you! You will be part of a small team in the QA department surrounded by energetic professionals in a fast-growing culture.
Within this department, you will fulfil a key role in implementing the MDR requirements throughout the entire product development process. As a QA/RA Specialist, you will act as a point of contact and be responsible for the QMS maintenance and improvement, the internal/external audits, you will be generating technical files and you will be contributing to regulatory-related tasks.
We’re looking for someone with the following profile:
- A bachelor’s degree or master’s degree in pharmaceutical sciences, biomedical sciences, or equivalent
- Strong experience with ISO 13485
- Experience with QMS maintenance and improvement
- Knowledge of the new MDR standards
- Strong verbal and written communication skills in both Dutch and English
- Problem-solving abilities
- Eye for detail
The organisation can provide you with the following:
- Opportunity to grow your skills in a dynamic and cooperative organisation
- High-level of independence
- Competitive salary package
- The workweek of max. 40 hours
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Associate | Biotech/Pharma division
+31 6 13 62 78 20
+31 23 754 86 60