Quality Assurance
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You will be working closely with the engineers to develop products. That will also be an opportunity to follow the whole process from A to Z and have your word
The QA/RA Associate shall provide support for the development of innovative medical devices, as part of the QA/RA team.
(S)he will provide support in Quality Assurance and Regulatory Affairs activities such as, but not limited to:
- Quality Management System implementation
- Standards watch and gap analysis
- Audits
- Compilation of documentation for notified bodies, FDA, competent authorities
Your responsibilities
- Good understanding of medical devices regulatory environment (MDD 93/42, MDR)
- Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards
- Work cross-functionally in identify and resolve various quality issues, participate in CAPA management
- Promote a quality culture throughout the company
- English and French/Dutch
You are
- Passionate about life sciences, technology and innovation
- Quality and customer-service oriented
- Focused on details
- Strong communication and organizational skills
- Autonomous & quick learner
- Flexible & open-minded
Your qualifications
- Min. 2 years of relevant experience in medical devices QA/RA functions
- Knowledge of QMS
- Fluent in English and French
Offer & benefits
- The opportunity to contribute to the development of products that will improve or save people's life
- A valorizing job within an ambitious and growing company in a booming industry
- A great team of enthusiastic people led by passionate experts in MedTech
- A nice working environment in Brussels, very close to the forest of Soignes, a park, nice shops and restaurants, public transport connections
- And of course, a good salary package and extra benefits
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