CAPA / Quality Events Analyst (Hybrid)

Role 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.

Responsibilities

• Manage CAPA and Quality Event records in alignment with Caris‚Äô 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.

Qualifications

• Bachelor‚Äôs 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) ‚Äì 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 Qualifications

• 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.

Physical Demands

• Work is primarily performed in an office or hybrid laboratory environment using standard office equipment.
• 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.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.