3rd Party Audits / Inspections: Participate in QMS audits of Cleveland Diagnostics by regulators, customers, Notified Body, or registrars (ISO certification and surveillance audits), and lead the remediation of audit findings. Deviations: Support identification and resolution of events, perform risk and impact assessment, implement immediate corrections, perform root cause investigation, determine corrective action plans, carry out remediations, and drive on time closure.