QA Manager

The role

You will have full ownership of the QMS, working on EU MDR and US QMSR. You will maintain procedures, manage nonconformities and complaints, lead audits, and train the company on quality practices.

What you will do

• Maintain and update the QMS
• Manage nonconformities and complaints
• Lead all audit phases including preparation, run, and follow-up
• Onboard new hires on QA practices and processes
• Run regular training and refreshers for existing teams
• Keep training material up to date
• Align QMS and ISMS processes
• Support HITRUST / SOC 2 audit readiness

Required qualifications

• Interest in our mission is critical
• 5 years of QMS management experience in software as a medical device
• Strong knowledge of the MDR (Medical Device Regulation, Europe) and the QMSR (Quality Management System Regulation, USA)
• Experience leading audits
• Experience in post-market surveillance (PMS) and vigilance processes
• Proven experience automating tools and processes
• Experience building a quality culture
• Good English communication

Nice to have

• Exposure to ISO 27001, SOC 2, or HITRUST

About the company

Sonio uses artificial intelligence to improve prenatal screening and diagnosis. The company aims to improve women's and children's health through technological innovation, medical expertise, and collective intelligence.