Vice President of Design Quality

Job Summary

Leading the establishment of a world-class Design Quality organization, the full-time remote Vice President of Design Quality will manage quality activities across hardware and software, ensuring compliance with global regulatory requirements while driving innovation and operational excellence.

Key responsibilities

• Lead and scale the Design Quality organization, embedding quality in product development and lifecycle management
• Oversee quality and regulatory leadership throughout the product lifecycle, ensuring compliance with relevant standards and regulations
• Manage enterprise product risk functions, ensuring risk-based decision-making is integrated across product development

Required qualifications

• 15+ years of progressive leadership experience in Medical Device Quality and/or Design Quality
• Proven experience leading Design Quality organizations across the product development lifecycle
• Expertise in design controls, design transfer, and risk management
• Significant experience with FDA inspections, audit management, and regulatory compliance
• Strong understanding of FDA regulations, ISO 13485, and global regulatory requirements