R&D · RAQA
ABOUT SONIO
Each year, 140M children are born. Birth defects affect 1 in 33 births in developed countries, and in 50% of cases, they are not detected during prenatal examinations. Prenatal medicine is particularly complex, and the scans impose heavy responsibilities on healthcare professionals. They can also be a source of stress for future parents.
Resulting from 5 years of collaboration between world-renowned experts from Necker Hospital and Ecole Polytechnique, Sonio uses artificial intelligence to improve prenatal screening and diagnosis. Based on patented algorithms and a proprietary expert database, Sonio aims to become the reference tool to help practitioners improve screening, reduce diagnostic errors, and optimize pregnant women’s medical path.
Sonio's mission is to improve women's and children's health by promoting access and quality of care through technological innovation, medical expertise, and collective intelligence.
About the role
You'll have full ownership of our QMS, working on both EU MDR and US QMSR.
You'll report directly to Zahra, our Head of RAQA, and be the face of Sonio's quality, ensuring our processes scale as we grow and leading audits directly.
Your responsibilities
- Own the QMS: maintain it, update procedures, and manage nonconformities and complaints, with a strong appetite for automation (Notion, HubSpot, n8n, Claude).
- Lead all the audit phases: preparation, run, and follow-up
- Train and upskill the company on quality: onboard all new hires on QA practices and processes, run regular training and refreshers f