Lead Auditor, Quality Compliance
$109.25k - $149.5kIntegra LifeSciences Corporation
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
Vacancy posted a month ago
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