Events

• Manage CAPA and Quality Event records in alignment with Caris’ Quality System procedures and applicable external requirements (FDA 21 CFR, ISO 13485, CAP/CLIA, PMDA, CMDCAS, and other global regulatory frameworks).
• Lead investigations for Quality Events, Deviations, and Nonconformances from initiation through closure, ensuring accurate classification, root cause analysis, and timely documentation.
• Support trending and data analysis activities to identify recurring issues, systemic gaps, and improvement opportunities across departments.
• Liaise with internal partners to facilitate investigations, collect objective evidence, and verify the effectiveness of corrective and preventive actions.
• Maintain accurate, audit-ready documentation across all stages of CAPA and Quality Event lifecycle, ensuring traceability and timeliness.
• Evaluate technical and operational data to confirm adequacy of corrective actions and resolution documentation.
• Serve as a Subject Matter Expert (SME) for CAPA and Quality Event processes, ensuring compliance, consistency, and accuracy in all related records.
• Provide input into quality training programs and support continuous improvement initiatives to strengthen CAPA and Quality Event management effectiveness.
• Collaborate with Quality leadership to align CAPA and QE procedures across departments and integrate analytics into routine governance reviews.
• Prepare for and support internal and external audits, maintaining documentation to ensure readiness for inspections and assessments.
• Actively contribute to continuous improvement efforts by identifying trends, recommending procedural enhancements, and participating in cross-functional CAPA planning.
• Support reporting of Quality Event and CAPA metrics to management through dashboards, trending summaries, and data-driven presentations.
• Perform other duties as assigned in support of departmental or enterprise-wide quality objectives.

CAPA, Quality Events Analyst

Senior Manager, Event Management

Associate Director – Events

Senior Data Loss Prevention Engineer

Sales and Events Manager