CAPA / Quality Events 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 / Quality Events Analyst primarily responsible for ensuring the integrity and effectiveness of Caris Life Sciences’ CAPA and Quality Events programs. This role integrates investigation management, trending analysis, and effectiveness verification to ensure that product, process, and services issued are identified, resolved, and prevented in alignment with regulatory and internal Quality Systems requirements.

The Analyst partners cross-functionally with internal stakeholders across laboratory, operational, and customer-facing functions to maintain compliance with FDA, ISO 13485, CAP, and CLIA standards while driving proactive identification of trends and continuous improvement opportunities.

This position is a key contributor to Caris’ enterprise Quality System, ensuring robust CAPA governance, effective Quality Event triage, and end-to-end documentation control. The Analyst supports internal audits, data-driven quality reviews, and CAPA verification to strengthen audit readiness and operational reliability across all business units.

Job Responsibilities

• 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.

Required Qualifications

• Bachelor’s degree in a scientific, engineering or health-related field (e.g., Biology, Chemistry, Biomedical Engineering, or related discipline).

• 3-5 years of experience in a regulated Quality environment such as Medical Devices, Diagnostics, or Clinical Laboratories