Quality & Compliance Lead — Medical Device QMS & Audits

Sonio; Paris (TX); On-site; USD 67,000 - 73,000; Full time

Job summary

Sonio, Paris-based, seeks a seasoned QA/QMS leader to own and scale the QMS for EU MDR and US QMSR. You will report to the Head of RAQA, drive audit readiness, and integrate ISMS alignment while promoting a strong quality culture across the organization.

You will automate document control and improvements using Notion, HubSpot, and related tools, and train teams to sustain high-quality delivery for end users in a fast-moving medical software environment.

Qualifications

• 5 years of QMS management experience in software as a medical device.
• Strong knowledge of MDR (EU) and QMSR (USA).
• Experience leading audits across phases: prep, run, follow-up.
• Experience in post-market surveillance (PMS) and vigilance processes.

Responsibilities

• Own the QMS: maintain it, update procedures, and manage nonconformities and complaints, with automation focus (Notion, HubSpot, n8n, Claude).
• Lead all the audit phases: preparation, run, and follow-up.
• Train and upskill the company on quality: onboard new hires on QA practices, run regular training, refreshers, and keep materials up to date.
• Contribute to the ISMS alongside the security team: align QMS and ISMS processes and support HITRUST / SOC 2 audit readiness.

Skills

QMS management

MDR / QMSR knowledge

Audit leadership

Process automation

English communication

Tools

Notion

HubSpot

n8n

Claude

Job description

Sonio, Paris-based, seeks a seasoned QA/QMS leader to own and scale the QMS for EU MDR and US QMSR. You will report to the Head of RAQA, drive audit readiness, and integrate ISMS alignment while promoting a strong quality culture across the organization.

You will automate document control and improvements using Notion, HubSpot, and related tools, and train teams to sustain high-quality delivery for end users in a fast-moving medical software environment.