CAPA Remediation Specialist Location: Remote Work Schedule: Must be available to work during US EST/CST business hours Employment Type: Full-Time Job Summary The CAPA Remediation Specialist will support the review, remediation, documentation, and closure of Corrective and Preventive Actions within the Quality Management System. The role will assess existing CAPA records, identify compliance gaps, improve root-cause analyses, update corrective-action plans, and ensure CAPAs meet applicable regulatory and internal quality requirements. The idóneo candidate will have strong experience in medical-device quality systems, CAPA remediation, root-cause analysis, effectiveness verification, and regulatory compliance. Essential Duties and Responsibilities Review open, overdue, and closed CAPA records for completeness, accuracy, and compliance. Conduct retrospective assessments of CAPA documentation and identify deficiencies or missing evidence. Evaluate problem statements, scope definitions, containment actions, risk assessments, and investigation records.



Review and improve root-cause analyses using methodologies such as 5-Why, Fishbone, Fault Tree Analysis, and related tools. Develop or update corrective and preventive action plans based on identified root causes and risk. Ensure CAPA actions are measurable, time-bound, appropriately documented, and traceable. Review supporting evidence, including SOP updates, training records, validation documentation, investigation reports, and trend data. Assess CAPA effectiveness checks and confirm that acceptance criteria demonstrate prevention of recurrence. Verify appropriate linkage between CAPAs and complaints, deviations, nonconformances, audit findings, and other quality records. Document remediation findings, recommendations, decisions, and completed actions within the electronic Quality Management System. Escalate compliance risks, overdue actions, and unresolved CAPA deficiencies to quality leadership. Support CAPA metrics, sta

📌 CAPA Remediation Specialist (México)
🏢 Intellectt
📍 México