QA Manager
Sonio· R&D
Hybrid (Paris office)$60k - $65kFull-timePosted 1w ago
About the role
QA Manager at Sonio responsible for owning and scaling the QMS (EU MDR and US QMSR), leading audits, training on QA practices, and aligning QMS with ISMS to support HITRUST / SOC 2 readiness, while fostering a culture of quality.
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 for existing teams, and keep training material up to date as processes evolve.
- 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.
- Build a shared quality culture, ensuring processes support the team's work and have a real impact on end-user quality delivery.
Qualifications
- 5 years of QMS management experience in software as a medical device.
- Strong knowledge of the MDR (Medical Device Regulation, Europe) and the QMSR (Quality Management System Regulation, USA).
- Experience leading audits.
- Experience in post-market surveillance (PMS) and vigilance processes.
- Proven experience automating tools and processes.
- Experience building a quality culture with good English communication.
- Exposure to ISO 27001, SOC 2, or HITRUST is a plus.
Skills
Required:QMS managementRegulatory knowledge (MDR, QMSR)AuditingAutomation of QA processes
Benefits
- Salary: 60-65K + 10%
- Location: Paris (Hybrid)
- Employee-focused process with quick interview-to-offer timeline (aim for <= 1 month)
- Opportunity to influence quality across the organization and audits
Last updated Oct 14, 2026. Interested? Apply on the company site.
About Sonio
Ultrasound and clinical workflows made easy with AI
Sonio is a cloud-based ultrasound OB-GYN reporting software using clinical AI* to bring efficiency and quality control to your practice’s workflow.
UltrasoundOB-GYNClinical WorkflowsAI
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