Audit Program Specialist

Integra LifeSciences•Columbia, MD

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Audit Program Specialist supports the corporate internal quality audit program within Integra Lifesciences. This role is responsible for supporting the auditor team in coordinating and administering all stages of the corporate internal audit lifecycle, including audit scheduling, planning, execution logistics, report generation, review and approval facilitation, corrective and preventive action (CAPA) tracking, and performance metric reporting. The position ensures audits are conducted in compliance with corporate policies, FDA QMSR, ISO 13485, MDSAP, EU MDR, and other applicable global regulatory requirements.

Requirements

Bachelor’s degree in Engineering, Science, Quality, or related field
3-5 years in quality or compliance roles
Experience with FDA QMSR, ISO 13485, MDSAP
Strong organization and communication skills
Proficiency with quality systems and Microsoft Office
Experience in FDA controlled environment
Strong collaboration skills and experience working in a matrix environment

Responsibilities

Coordinate the annual internal audit schedule, approval, and revisions
Support audit planning, scope definition, agenda creation, and audit logistics
Facilitate audit execution for onsite and remote audits
Support auditors with drafting audit reports
Manage cross-functional review and approval of audit reports
Track auditee responses and audit action item status
Maintain audit records and databases
Responsible for auditor training and certification maintenance
Prepare audit metrics and dashboards
Supports continuous improvement of audit processes including TrackWise audit module
Assists with site-level preparation for external inspections
Perform other related duties as expected