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

If you are striving to learn new things and discover the challenges that come with developing and placing into the market a medical device, our QARA team is looking for a Quality Assurance Intern. Your role will be to support our team by continuously improving internal processes and ensuring compliance with regulations.

Key Missions

Under the supervision of the Senior Quality Assurance Manager, you will:

• Support the maintenance and continuous improvement of the Quality Management System (QMS) in accordance with ISO 13485

• Write, review, and maintain quality documentation (procedures, work instructions, templates, records) and ensure proper document control

• Support software validation activities, including validation documentation, traceability, and evidence maintenance

• Assist in the management of nonconformities, complaints, and CAPAs (investigation support, documentation, follow-up, verification of effectiveness)

• Contribute to continuous improvement initiatives and quality process optimization

• Support the definition and monitoring of quality indicators (KPIs)

• Support quality training activities, including the preparation, deployment, and follow-up of internal training and training records

About the profile

• Support the use and improvement of digital QMS tools and quality workflows

• Ongoing Bac+5 in the medical devices field in preference (engineering degree, master in regulatory affairs…)

• Knowledge of medical devices and software is a plus

• Knowledge in quality and regulatory affairs is a plus

• You are perfectly fluent in French and English

• You value teamwork, and you are team-oriented. This role will interact with most of the teams internally. Moreover, happiness and well-being are a priority in the way we’re building the team, and we also want to be innovative here!

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 [email protected].