Vice President, Corporate Quality Systems
Integra LifeSciences · Headquarters, NJ +3 more
QualityFull-time$225k–$316kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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