QA & Compliance Leader, Medical Device Software (MDR/QMSR)

Sonio; Paris; On-site; EUR 60,000 - 65,000; Full time

Job summary

Sonio is seeking a Quality & RAQA leader to own the QMS and drive audit readiness across the EU MDR and US QMSR. You will report to the Head of RAQA and scale processes as the company grows, ensuring end-to-end quality and regulatory compliance.

You’ll build a quality culture, train teams, and align QMS with ISMS, while supporting HITRUST/SOC 2 readiness and incident management in a fast-moving medical device software environment. Paris-based role.

Qualifications

• 5+ years of QMS management experience in software as a medical device.
• Strong knowledge of the MDR (EU) and the QMSR (US).
• Experience leading audits.
• Experience in post-market surveillance (PMS) and vigilance processes.
• Proven experience automating tools and processes.
• Good English communication to onboard teams.
• Exposure to ISO 27001, SOC 2, or HITRUST is a plus.

Responsibilities

• Own the QMS: maintain it, update procedures, manage nonconformities and complaints; explore automation with the listed tools.
• Lead all audit phases: preparation, execution, follow-up.
• Train and upskill the company on QA practices; onboard new hires; keep training material up to date.
• Contribute to the ISMS alongside security: align QMS and ISMS processes and support audit readiness (HITRUST / SOC 2).

Skills

QMS management

Audit leadership

Automation of tools

Quality culture & English comms

MDR & QMSR knowledge

PMS & vigilance processes

ISO 27001 / SOC 2 / HITRUST exposure

Tools

Notion

HubSpot

n8n

Claude

Job description

Sonio is seeking a Quality & RAQA leader to own the QMS and drive audit readiness across the EU MDR and US QMSR. You will report to the Head of RAQA and scale processes as the company grows, ensuring end-to-end quality and regulatory compliance.

You’ll build a quality culture, train teams, and align QMS with ISMS, while supporting HITRUST/SOC 2 readiness and incident management in a fast-moving medical device software environment. Paris-based role.