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Caris Life Sciences · 18 hours ago

CAPA & Complaints Analyst (Hybrid)

Phoenix, AZ

Full-time

Hybrid

Mid Level

3+ years exp

Caris Life Sciences is dedicated to transforming cancer care and improving lives through precision medicine. The CAPA & Complaints Analyst plays a vital role in quality oversight for CAPA and complaint handling processes, ensuring compliance with regulatory standards while driving continuous improvement initiatives.

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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

Qualification

Quality experienceComplaint HandlingCAPA processesRegulatory standardsQMS proficiencyData management systemsAnalytical skillsCommunication skillsProblem-solving skillsTeam collaborationAttention to detailCustomer focus

Required

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

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