Manager, Quality Assurance

Lead the Quality Management System (QMS) for medical device programs, guiding project teams to ensure ISO13485:2016 compliance across hardware, software, and AI/ML-enabled designs. Drive quality planning, maintain quality records, internal audits, and regulatory readiness; develop SOPs, templates, and training; manage documentation control and continuous improvement; interface with regulators and participate in medical device submissions and regulatory inspections. This hands-on, senior role requires expertise in design controls, DHF/RTM, risk management, V&V, and eQMS/CSV activities, with the ability to lead cross-functional teams from ideation to commercial distribution. Desired focus includes AI/ML-enabled SaMD, US FDA submissions (510(K), PMA), IEC standards, and ongoing quality improvements across hardware, software, and systems.