Vice President, Corporate Quality Systems

Integra LifeSciences seeks a Vice President of Corporate Quality Systems to design, implement, and oversee a global quality infrastructure across manufacturing and distribution facilities. This leadership role ensures compliance with FDA, ISO 13485, and international regulations while managing a corporate quality team and driving continuous improvement.

Responsibilities

• Build high-performance quality culture and lead corporate quality team across CAPA, compliance, training, and post-market surveillance functions
• Develop organizational governance and strategic direction aligned with Compliance Master Plan and business objectives
• Design and oversee global quality system evolution, establishing KPIs and monitoring compliance remediation effectiveness
• Lead identification and resolution of quality issues and non-conformities across departments through QMS
• Support regulatory interactions and ensure organizational readiness with FDA, EU, and other regulatory bodies

Requirements

• Bachelor's degree in engineering, science, or related technical discipline; master's degree preferred
• 18+ years of team leadership or management experience in regulated industries
• Medical device and/or pharmaceutical experience with material remediation background
• Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, MDR, and international standards
• Direct experience with FDA and EU Notified Body interactions
• Expertise in process design, change control, auditing, and document management systems
• Strong cross-functional collaboration, change management, and executive communication skills