Senior Audit Program Specialist

Role: Senior Audit Program Specialist supporting Integra Lifesciences' internal quality audit program. Objectives: coordinate and administer all stages of internal audits to ensure compliance with FDA QMSR, ISO 13485, MDSAP, EU MDR, and global regulations. Responsibilities: manage annual audit schedules, support audit planning, facilitate onsite and remote audits, assist with report drafting, track CAPA responses, maintain audit records and metrics, support external inspection prep, and contribute to continuous process improvement. Requirements: Bachelor’s in Engineering, Science, Quality, or related field; minimum 5 years in quality/compliance roles (or 3 years with advanced degree); experience with FDA QMSR, ISO 13485, MDSAP; strong organization, communication, and collaboration skills; proficiency with quality systems and MS Office; experience in FDA-controlled environments. Preferred: experience in medical device quality systems. High-Value: medical device industry, global regulatory compliance, GxP, quality management systems, audit lifecycle management, site inspection readiness. Work setup: Up to 20% travel; primarily office-based with some remote work.