Roles & Responsibilities: Act as Lead Auditor. Audit client management systems for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485 - 2016 Assist clients with questions relevant to the audit and/or certification process. Coordinate audit activity with team members. Liaison with the client regarding audit activity. Review client's quality management system documentation Verify and Validate document evidence of compliance and non-compliance. Prepare audit report. Review audit results with the coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required. Assist with corrective action requirements resulting from assessments. Participate in audit meetings.Review audit reports and provide technical assistance to the Internal/External Team Support management in areas of continuous improvement. Plan ISO/CE/FDA audits by preparing and communicating audit plans. Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews of employees for compliance. Communicate audit results through the preparation and publication of audit reports. Follow-up audit results by seeking appropriate corrective actions if deficiencies are noted. Track implementation of corrective actions and verify actions for effectiveness. Support management on tracking audit activities and administration of audit schedule. Support external audits including interfacing with regulatory agencies and registrars if necessary. Lead and support projects and initiatives to achieve Quality Systems objectives and any other regulatory objectives (e.g., QSR training, Quality Systems initiatives, etc.).