Director, Software Design QA

Lead QA strategy and team for medical software at Neko Health.

• •Neko Health is seeking a Director, Software Design QA to lead quality assurance strategy and execution for their innovative medical technologies.
• •This role involves owning design control, risk management, and regulatory compliance for cloud-based and SaaS platforms.
• •Key Responsibilities Drive the overall QA strategy and philosophy in the software lifecycle domain.
• •Lead and develop a growing QA team with an engineering mindset.
• •Define and implement AI-driven QA processes and automated workflows.
• •Own design control and risk management strategies for software medical devices.
• •Build and maintain audit-ready technical documentation and Design History Files (DHFs).
• •Requirements Experience in driving QA strategy and leading QA teams.
• •Expertise in design control, risk management, and regulatory compliance (IEC 62304, EU MDR, FDA).
• •Proficiency in building and maintaining technical documentation and DHFs.