Lead Auditor, Quality Compliance

Lead Auditor for Quality Compliance at Integra LifeSciences will direct internal audits of the Quality Management System across 15+ medical device design, manufacturing, and distribution facilities. The role involves conducting corporate audits, evaluating compliance with GMP and ISO standards, and serving as a subject matter expert to support organizational quality initiatives.

Responsibilities

• Lead and execute corporate audits of Quality Management System across multiple facilities
• Prepare formal audit reports with findings, recommendations, and site classifications
• Identify compliance gaps and support sites in implementing improvements and corrective actions
• Provide subject matter expertise on quality topics to audit teams and broader organization
• Support regulatory inspection readiness through audits, mock inspections, and team coaching

Requirements

• Extensive GMP audit experience with demonstrated practical auditing skills
• Strong technical writing ability and objective judgment on compliance issues
• Knowledge of ISO, GMP, GDP, GCP, and GLP standards and requirements
• Project and time management capabilities with ability to work independently or lead teams
• Excellent interpersonal and communication skills with cross-cultural sensitivity
• Proven ability to develop audit reports and assess corrective action proposals