Director of Quality

About the Role We’re looking for a Quality Director to lead and evolve our quality function as we scale regulated medical devices that incorporate AI/ML software. This role sits at the intersection of hardware, software, and data science and will be critical in ensuring our products meet regulatory requirements while maintaining development velocity. You’ll report to the VP of Quality & Regulatory and work closely with Engineering, Regulatory, Clinical, and Operations. The right person for this role is comfortable in a fast-moving environment and knows how to build practical, right-sized quality systems. What You’ll Do Lead the Quality Function Own and continuously improve our Quality Management System (QMS) Lead and develop a small but growing quality team Establish KPIs and reporting for executive leadership Serve as the quality voice at the leadership table Ensure Regulatory Compliance Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR Prepare for and lead FDA inspections, ISO surveillance audits, and notified body audits Support regulatory submissions from a quality perspective Monitor evolving FDA guidance on AI/ML-enabled devices and ensure alignment Support Product Development Embed Design Controls into hardware and software development processes Ensure compliance with IEC 62304 for software lifecycle processes Oversee risk management activities (ISO 14971), including FMEA and hazard analysis Partner with Data Science teams on AI model lifecycle controls (training data management, model updates, change control, performance monitoring) Post-Market & CAPA Oversee complaint handling, MDR reporting, and CAPA processes Drive investigations and ensure root cause analyses are thorough and actionable Use data trending to proactively identify quality risks Supplier & Manufacturing Quality Establish and maintain supplier qualification and audit processes Oversee incoming inspection and production quality controls Partner with Operations to ensure scalable manufacturing processes What you'll do Experience 10+ years in quality roles within medical devices or regulated healthcare software At least 3–5 years in a leadership capacity Direct experience with FDA inspections and ISO 13485 audits Experience supporting both hardware and software products Familiarity with AI/ML in a regulated environment strongly preferred Technical Knowledge Deep understanding of: FDA QSR (21 CFR 820) and ISO 13485 ISO 14971 risk management IEC 62304 software lifecycle requirements Working knowledge of Agile/Scrum environments Comfort reviewing technical documentation and working closely with engineers and data scientists Leadership Style Hands-on and pragmatic Comfortable operating in ambiguity and growth environments Able to push back when needed Strong communicator with auditors, executives, and technical teams Nice to Have Experience with Software as a Medical Device (SaMD) Background in AI/ML model governance or data quality controls ASQ certification (CQE, CMQ/OE, etc.) Prior experience in venture-backed or scaling organizations

Created: 2026-03-11