|At Sirius we improve care for cancer patients through our effective, affordable localization system, enabling the precise and efficient surgical removal of tumors. Our ambition is to offer a solution that provides value across the patient-care pathway. Our aim is that our system becomes accessible to every breast cancer center looking for a better alternative.
Our Sirius Pintuition system has MDD-CE mark since 2020 and US FDA-510(k) clearance since early 2021. We are running initial commercial business in EU and are preparing US sales. In parallel, we develop new innovative features for our products, requiring MDR transition of our dossiers and keeping our regulatory dossiers for FDA up to date.
To support the growth of our activities, we seek support from an experienced quality assurance officer with the potential to grow towards quality assurance manager position. You will join a small multi-disciplinary team of medical device experts (technology, clinical, quality, business, operational) in which you assure compliance with our ISO 13485:2016 certified and 21 CFR part 820 compliant QMS.
- You manage our quality system processes (a.o. non-conformities, complaints, CAPA’s, and changes)
- You take ownership of document and record management (DHF/DMR/DHR)
- You prepare production and release documentation
- You perform supplier evaluation activities
- You contribute to product development with quality reviews, design reviews, and risk assessments
- You support MDD to MDR transition of our technical files and maintenance of our 510(k) dossiers