QA Manager

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

Job summary

Sonio is seeking a QA leader to own and scale our QMS, overseeing EU MDR and US QMSR. You will drive audits, train teams, and partner with security to align ISMS efforts. Strong automation experience and English communication are essential.

You will report to the Head of RAQA and shape the quality culture as we grow, ensuring end-user quality delivery across the organization.

Qualifications

• 5 years of QMS management 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.
• Builds a quality culture with good English communication.
• Exposure to ISO 27001, SOC 2 or HITRUST is a plus.

Responsibilities

• Own the QMS: maintain procedures, nonconformities, and complaints with a focus on automation.
• Lead all audit phases: preparation, execution, and follow-up.
• Train and upskill the company on QA practices and processes.
• Contribute to the ISMS alongside the security team: align QMS and ISMS processes and support HITRUST / SOC 2 audit readiness.

Skills

QMS management

Audit leadership

PMS & vigilance

Process automation

Quality culture

MDR & QMSR knowledge

English communication

Tools

Notion

HubSpot

n8n

Claude

Job description

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 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.

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.

About The Profile

Sonio is a mission-driven company, so interest in our mission is critical. Other requirements are:

• 5 years of QMS management experience in software as a medical device. You bring strong knowledge of the MDR (Medical Device Regulation, Europe) and the QMSR (Quality Management System Regulation, USA).
• You have experience leading audits.
• Experience in post-market surveillance (PMS) and vigilance processes.
• Proven experience automating tools and processes.
• You have experience building a quality culture with good English communication that allows you to get people on board with what you’re building.
• Exposure to ISO 27001, SOC 2, or HITRUST is a plus.

Location

Paris

Salary

60-65K + 10%