CAPA & Complaints Analyst; Hybrid

Position: CAPA & Complaints Analyst (Hybrid)
** At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives.
** We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: _"What would I do if this patient were my mom?"_ That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose.

** Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.*
* ** Position Summary
** The CAPA & Complaints Analyst provides day-to-day quality oversight for Corrective and Preventive Actions (CAPA) and Complaint Handling processes within Caris Life Sciences. This position integrates investigation management, trending analysis, and effectiveness verification to ensure product, process, and service issues are identified, resolved, and prevented. The CAPA & Complaints Analyst works cross-functionally with internal partners across laboratory, operational, and customer-facing functions to maintain compliance with FDA, ISO 13485, CAP, and CLIA requirements while driving data-informed continuous improvement.

This position serves as a key contributor to Caris' enterprise Quality System, ensuring compliant, accurate, and timely complaint resolution and CAPA integration. The analyst supports complaint investigations through closure while partnering with internal teams to identify systemic trends, drive corrective actions, and strengthen audit readiness. The role operates within Caris' global Quality System and Regulatory framework, maintaining compliance with applicable FDA, ISO 13485, CAP, and CLIA standards.

The analyst contributes to continuous improvement initiatives that enhance data integrity, product quality, and patient safety across all business lines.
** Job Responsibilities** + Manage CAPA and Complaint records in alignment with Caris' Quality System procedures and applicable external requirements and standards, including FDA (21 CFR), ISO 13485, CMDCAS, PMDA, CAP/CLIA, New York State and other national and/or worldwide regulatory agencies, Health & Safety Practices, and other applicable standards as pertaining to medical devices. + 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 across laboratory, operational, and customer-facing functions 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, traceability, and timely updates. + Review reportable and potentially reportable complaints, collaborating with the Quality and Regulatory teams to ensure proper evaluation and submission to applicable authorities.

+ Evaluate information from both clinical and technical perspectives to confirm appropriate investigation, resolution, and closure documentation. + Serve as a Subject Matter Expert (SME) for Complaint Handling, CAPA integration, and related regulatory reporting (MDR, PMS), ensuring compliance, accuracy, and consistency in all related activities and documentation. + 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 across departments. + Contribute to internal and external audit readiness by maintaining up-to-date documentation and supporting audit responses as needed. + Ensure personal and company compliance with all Federal, State, and international regulations, as well as Caris policies and procedures for Health, Safety, and Environmental compliance.

+ Perform other duties as assigned to support the Quality Management System and enterprise quality objectives.
** Required Qualifications** + Bachelor's degree in a related scientific or technical field (e.g., biology, biotechnology, chemistry, medical technology, or engineering). + 3-5 years of professional Quality experience within Medical Devices, Clinical Laboratories, or IVD environments. + Direct experience supporting Complaint Handling, CAPA, Deviations, or related Quality System processes. + Working knowledge of applicable regulatory standards and frameworks, including FDA (21 CFR), ISO 13485,…