Katalyst Healthcares & Life Sciences
Sr. Principal Software Quality Engineer
Katalyst Healthcares & Life Sciences, Bellevue, Washington, United States, 98009
Job Title
Responsibilities: Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards. Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls. Lead software risk management (RMF), including risk evaluation, control, and mitigation. Drive Secure Product Development F...
Responsibilities: Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards. Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls. Lead software risk management (RMF), including risk evaluation, control, and mitigation. Drive Secure Product Development F...