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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, CAP/CLIA, and other international regulations.

• Proficiency in QMS and data management systems, such as DOT Compliance, Master Control, Veeva, Trackwise or equivalent platforms, with strong understanding of investigation workflows and record traceability.

• Strong analytical and documentation skills with attention to accuracy, completeness, and regulatory integrity.

• Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and comfortable using digital dashboards or analytics tools for trending and reporting.

Preferred Qualifications

• Demonstrated success working independently and collaboratively within cross-functional and matrixed teams.

• Exceptional communication and problem-solving skills, with the ability to translate complex quality or technical information for diverse stakeholders.

• Strong data-driven mindset with experience using analytics to identify trends, assess root causes, and propose continuous improvement opportunities.

• Proven ability to manage multiple priorities in a regulated environment while maintaining accuracy, compliance, and documentation discipline.

• Experience supporting global Quality Systems and understanding of U.S. and international medical device and laboratory regulations.

• Drive for Results — consistently delivers on quality and compliance objectives through initiative, accountability, and proactive engagement.

• Commitment to Continuous Improvement — seeks innovative, efficient solutions that enhance quality performance and audit readiness.

• Customer and Stakeholder Focus — builds trusted relationships through responsiveness, transparency, and data-supported decision-making.

• Strong written and verbal communication skills, including preparation of audit responses, CAPA summaries, and management presentations.

• Ability to adapt to evolving priorities, work under minimal supervision, and thrive in a fast-paced environment requiring attention to both detail and timelines.

Physical Demands

• Work is primarily performed in an office environment requiring routine use of standard office equipment (computer, phone, copier, etc.).

• Must be able to sit or stand for extended periods while reviewing documents, conducting investigations, or entering data.

• Occasional lifting of up to 20 pounds may be required for document files or equipment.

• Visual acuity and manual dexterity required to review quality records, enter data, and prepare reports.

• Must be able to work at a computer for prolonged periods and perform repetitive keyboarding and data-entry tasks.

Training

• Completion of all assigned Quality System, regulatory, and safety training prior to assuming role responsibilities.

• Ongoing participation in continuing education and internal training programs to maintain up-to-date knowledge of applicable regulatory and compliance standards (e.g., FDA, ISO 13485, CAP/CLIA).

• Participation in cross-functional or role-specific training may be required to support continuous improvement, audit readiness, and employee development initiatives.

Other

• May require flexible scheduling or limited travel (<10%) to support audits, inspections, or cross-site quality initiatives.

• Must adhere to Caris Life Sciences’ policies, code of conduct, and confidentiality requirements.

• Position may occasionally require evening or weekend hours during audits, regulatory inspections, or critical quality events.

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.