Lead Auditor, Quality Compliance

Role: Lead Auditor, Quality Compliance within the Corporate Audit team, responsible for leading, coordinating, and performing audits of Integra LifeSciences' Quality Management System across multiple facilities producing medical devices. Objectives include ensuring compliance with ISO, GMP, GDP, GCP, and GLP standards, and supporting inspection readiness and continuous improvement. Responsibilities: conduct and oversee corporate audits, evaluate CAPAs, review self-certifications, provide technical consultancy, and contribute to audit process enhancements. Core focus areas involve GMP, GxP, medical device regulations (EU MDR, 21 CFR Part 820), and technical expertise in microbiology, sterilization, manufacturing, or related fields. Qualifications required include a Bachelor’s in engineering/sciences, 15+ years of audit experience in pharma/medtech, formal auditor certification, and extensive GMP audit background, preferably with experience in FDA-regulated environments and international standards. Preferred skills include multilingual capabilities, experience with supplier audits, and knowledge of EU and US regulatory requirements. The role involves international travel (up to 50%), with a focus on maintaining high audit standards and fostering a culture of quality compliance. The position reports to the corporate audit leadership and involves collaboration with multiple cross-functional teams to uphold product safety and regulatory adherence.