Senior Audit Program Specialist
$81.65k - $112.7kIntegra LifeSciences Corporation
Integra LifeSciences seeks a Senior Audit Program Specialist to manage the corporate internal quality audit program across multiple manufacturing facilities. The role coordinates audit scheduling, planning, execution, report generation, and corrective action tracking while ensuring compliance with FDA, ISO, and global regulatory standards.
Responsibilities
- Coordinate annual internal audit schedules, approvals, and revisions across facilities
- Support audit planning, scope definition, agenda development, and on-site/remote logistics
- Draft audit reports and facilitate cross-functional review and approval processes
- Track corrective and preventive actions and maintain audit records and databases
- Prepare audit metrics, dashboards, and support external inspection readiness
Requirements
- Bachelor's degree in Engineering, Science, Quality, or related field
- Minimum 5 years quality/compliance experience or advanced degree with 3 years experience
- Knowledge of FDA QMSR, ISO 13485, and MDSAP requirements
- Proficiency with quality systems and Microsoft Office applications
- Experience in FDA-regulated manufacturing environments
- Strong organizational and written/verbal communication skills
- Ability to collaborate effectively in matrix organizational structures
Compensation: $81,650.00 - $112,700.00 USD base salary
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