CAPA & Complaints Analyst (Hybrid)

Role Summary

The CAPA & Complaints Analyst provides day-to-day quality oversight for Corrective and Preventive Actions (CAPA) and Complaint Handling processes at Caris Life Sciences. The role integrates investigation management, trending analysis, and effectiveness verification to identify, resolve, and prevent product, process, and service issues. It works cross-functionally with laboratory, operational, and customer-facing teams to maintain compliance with FDA, ISO 13485, CAP, and CLIA requirements while driving data-informed continuous improvement.

Responsibilities

• Manage CAPA and Complaint records in alignment with Quality System procedures and applicable external requirements and standards (FDA 21 CFR, ISO 13485, CMDCAS, PMDA, CAP/CLIA, New York State, and other regulatory agencies).
• Lead complaint investigations from intake through closure, ensuring accurate classification, documentation, and root cause analysis within required timelines.
• Support trending and data analysis to identify recurring issues, systemic gaps, and opportunities for preventive or corrective actions.
• Liaise with internal partners to facilitate investigations, gather evidence, and verify effectiveness of implemented actions.
• Maintain audit-ready documentation and records through all stages of Complaints Handling, ensuring completeness and traceability.
• Review reportable and potentially reportable complaints, collaborating with Quality and Regulatory teams for proper evaluation and submission to authorities.
• Evaluate information from clinical and technical perspectives to confirm appropriate investigation, resolution, and closure documentation.
• Serve as SME for Complaint Handling, CAPA integration, and related regulatory reporting (MDR, PMS), ensuring compliance and accuracy in related activities.
• Provide input to training materials and participate in quality training initiatives to support enterprise complaint management and CAPA effectiveness.
• Collaborate with Quality leadership to drive continuous improvement and standardization of CAPA and Complaint processes.
• Contribute to audit readiness by maintaining up-to-date documentation and supporting audit responses.
• Ensure compliance with all applicable regulations and Caris policies for Health, Safety, and Environmental compliance.
• Perform other duties as assigned to support the Quality Management System and enterprise quality objectives.

Qualifications

• Required: Bachelor’s degree in a related scientific or technical field (e.g., biology, biotechnology, chemistry, medical technology, or engineering).
• Required: 3–5 years of professional Quality experience within Medical Devices, Clinical Laboratories, or IVD environments.
• Required: Direct experience supporting Complaint Handling, CAPA, Deviations, or related Quality System processes.
• Required: Working knowledge of regulatory standards and frameworks (FDA 21 CFR, ISO 13485, CAP/CLIA, and other international regulations).
• Required: Proficiency in QMS and data management systems (e.g., DOT Compliance, Master Control, Veeva, Trackwise or equivalent); strong understanding of investigation workflows and record traceability.
• Required: Strong analytical and documentation skills with attention to accuracy, completeness, and regulatory integrity.
• Required: Proficiency in Microsoft Office Suite and ability to use dashboards or analytics tools for trending and reporting.
• Preferred: Demonstrated success working independently and in cross-functional teams; strong communication and problem-solving skills; data-driven mindset; ability to manage multiple priorities in a regulated environment; experience supporting global Quality Systems.
• Preferred: Drive for results, commitment to continuous improvement, customer and stakeholder focus, strong written and verbal communication, and ability to adapt to evolving priorities.

Additional Requirements

• May require flexible scheduling or limited travel (<10%) to support audits, inspections, or cross-site quality initiatives.
• Must adhere to policies, code of conduct, and confidentiality requirements.
• Occasional evening or weekend hours may be required during audits, regulatory inspections, or critical quality events.
• Conditions of Employment: Pre-employment checks apply (criminal background check, drug screening, reference verification, and other checks as applicable).