Vice President, Corporate Quality Systems

Role: Vice President, Corporate Quality Systems, leading the design, implementation, and oversight of Integra's global quality system to ensure compliance with international regulations and standards for medical devices. Responsibilities: develop a high-performance quality culture; build and govern an integrated quality infrastructure across all facilities; collaborate with regulatory bodies and lead responses to authorities; manage quality issues and non-conformities through the QMS; promote continuous improvement using lean and Six Sigma methodologies; ensure compliance with FDA, ISO 13485, CMDR, MDR, MDSAP, and JPAL standards. Requirements: bachelor's degree in engineering, science, or related field; 18+ years of management experience, preferably in regulated industries such as medical devices or pharmaceuticals; deep knowledge of global regulatory requirements; strong leadership, strategic planning, and cross-functional collaboration skills; ability to travel up to 50%, with onsite presence in Massachusetts and New Jersey. HighValue: medical devices, global regulatory compliance, ISO 13485, FDA Part 820, international standards, quality system leadership, cross-functional stakeholder management, experience with remediation and process design.