Internal Audit Program Coordinator

Job Summary

The Internal Audit Program Coordinator supports and maintains the global internal audit program for a medical device organization operating under ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR requirements. This role is responsible for coordinating internal audits with qualified internal staff and external resources, as well as performing audits directly as experience grows. The Internal Auditor ensures audits are planned, executed, and documented in compliance with regulatory and quality system standards, contributing to continuous improvement and organizational compliance.

• Plan and coordinate the global internal audit schedule to ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR requirements
• Organize and facilitate internal audits by scheduling qualified internal auditors and external resources; accountable for ensuring audits are completed per established timelines and scope.
• Conduct internal audits (remo...