ФранцияQA Manager
вчера
ФранцияHybrid
notionhubspotn8nclaude
Manage and own the Quality Management System (QMS), leading audits and ensuring regulatory compliance in a MedTech company.
О компании
- 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, uses artificial intelligence to improve prenatal screening and diagnosis. Based on patented algorithms and a proprietary expert database, aims to become the reference tool to help practitioners improve screening, reduce diagnostic errors, and optimize pregnant women’s medical path.
- '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.
- 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%
- We move fast and aspire to be transparent over the process - our objective is that the process from the first chat to an offer is no longer than a month. We also aspire to give an answer to every application in a week - if you have not heard from us, please follow up at careers@.ai.
Обязанности
- 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 's quality, ensuring our processes scale as we grow and leading audits directly.
- 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.