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Caris Life Sciences · 8 hours ago

CAPA / Quality Events Analyst (Hybrid)

Phoenix, AZ

Full-time

Hybrid

Mid Level

3+ years exp

Caris Life Sciences is a pioneering company in precision medicine, dedicated to transforming cancer care and improving lives. The CAPA / Quality Events Analyst will ensure the integrity and effectiveness of CAPA and Quality Events programs while maintaining compliance with regulatory standards and driving continuous improvement initiatives across the organization.

Artificial Intelligence (AI)BiopharmaBiotechnologyHealth CareLife Science

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

Qualification

CAPA managementQuality Events analysisRoot cause analysisEQMS proficiencyRegulatory complianceData analysisMicrosoft Office SuiteCommunication skillsAttention to detailOrganizational skills

Required

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 (FDA, ISO 13485, CAP/CLIA)

Hands-on experience with CAPA, Quality Events, or Deviations, including investigation, documentation, and effectiveness verification

Working knowledge of root cause analysis tools (e.g. 5 Whys, Fishbone, FMEA) and corrective/preventive action principles

Proficiency with electronic Quality Management Systems (eQMS) – preferably DOT Compliance, MasterControl, Veeva, or equivalent

Strong analytical and documentation skills, with the ability to interpret data trends and summarize findings for managerial review

Proficient with Microsoft Office Suite (Word, Excel, Outlook) and comfortable creating dashboards or data visual summaries

Excellent written and verbal communication skills, including the ability to draft clear CAPA and QE records for audit and inspection readiness

Demonstrated ability to manage multiple priorities and meet deadlines in a dynamic, fast-paced environment

Preferred

Advanced understanding of CAPA systems and Quality Event lifecycle management, including integration with risk management and audit programs

Experience conducting cross-functional investigations involving laboratory, operational, or customer-facing teams to identify systemic process gaps

Proficiency in quality analytics or dashboard tools (e.g., Power BI, Excel Pivot tables, or embedded QMS analytics), for tracking trends and performance metrics

Familiarity with U.S. and International Quality System regulations (FDA 21 CFR 820/903) ISO 13485, CAP, CLIA, IVDR, PMDA, or equivalent)

Demonstrated ability to lead problem-solving or root cause analysis sessions (e.g., 8D, Ishikawa, 5 Whys, FMEA)

Strong written and verbal communication skills, with proven ability to summarize complex findings and prepare documentation suitable for regulatory inspection

Proven ability to collaborate across departments to drive CAPA and Quality Event closure, training alignment, and continuous improvement initiatives

Strong attention to detail and organizational skills, with a focus on data integrity, timeliness, and completeness

Commitment to continuous improvement and proactive quality leadership in a fast-paced regulated environment