QA Manager

<h1>About Sonio</h1><p style="min-height:1.5em"></p><p style="min-height:1.5em">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.</p><p style="min-height:1.5em"></p><p style="min-height:1.5em">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.</p><p style="min-height:1.5em"></p><p style="min-height:1.5em">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.</p><p style="min-height:1.5em"></p><p style="min-height:1.5em"></p><p style="min-height:1.5em"><strong>About the role</strong></p><p style="min-height:1.5em"></p><p style="min-height:1.5em">You'll have full ownership of our QMS, working on both EU MDR and US QMSR.</p><p style="min-height:1.5em">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.</p><p style="min-height:1.5em"></p><p style="min-height:1.5em"></p><p style="min-height:1.5em"><strong>Your responsibilities</strong></p><p style="min-height:1.5em"></p><ul style="min-height:1.5em"><li><p style="min-height:1.5em">Own the QMS: maintain it, update procedures, and manage nonconformities and complaints, with a strong appetite for automation (Notion, HubSpot, n8n, Claude).</p></li><li><p style="min-height:1.5em">Lead all the audit phases: preparation, run, and follow-up</p></li><li><p style="min-height:1.5em">Train and upskill the company on quality: onboard all new hires on QA practices and processes, run regular training and refreshers for existing teams, and keep training material up to date as processes evolve.</p></li><li><p style="min-height:1.5em">Contribute to the ISMS alongside the security team: align QMS and ISMS processes (document control, CAPA, internal audits) and support HITRUST / SOC 2 audit readiness.</p></li></ul><p style="min-height:1.5em">We expect this person to build a shared quality culture, not only by building processes, but also by ensuring they support the team's work and have a real impact on end-user quality delivery.</p><p style="min-height:1.5em"></p><p style="min-height:1.5em"></p><p style="min-height:1.5em"><strong>About the profile</strong></p><p style="min-height:1.5em"></p><p style="min-height:1.5em">Sonio is a mission-driven company, so interest in our mission is critical. Other requirements are:</p><ul style="min-height:1.5em"><li><p style="min-height:1.5em">5 years of QMS management experience in software as a medical device. You bring strong knowledge of the MDR (Medical Device Regulation, Europe) an