Lead Auditor, Quality Compliance
Integra LifeSciences · Facility, NJ +3 more
The apply link worked recently (not employer-confirmed).
Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Integra LifeSciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.