CAPA Remediation Specialist

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 ideal 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, status reporting, dashboards, and remediation-program reviews.
• Support internal audits, FDA inspections, Notified Body audits, and inspection-readiness activities.
• Collaborate with CAPA owners, Quality, Regulatory, Engineering, Manufacturing, Clinical, and remediation teams.
• Complete assigned CAPA-remediation activities within established project timelines.

Required Qualifications

• 10+ years of experience in Quality Assurance, Quality Systems, CAPA, or compliance within the medical-device industry.
• Strong hands-on experience with CAPA remediation, CAPA investigations, and effectiveness verification.
• Strong knowledge of root-cause-analysis methodologies and investigation tools.
• Experience reviewing and remediating quality-system documentation.
• Understanding of FDA quality-system requirements, ISO 13485, and applicable global medical-device regulations.
• Experience working with electronic Quality Management Systems.
• Strong technical-writing, documentation, analytical, and problem-solving skills.
• Ability to identify compliance gaps and provide clear remediation recommendations.
• Strong written and verbal communication skills.
• Ability to work independently and collaborate with cross-functional teams.

Preferred Qualifications

• Experience supporting FDA inspection remediation or regulatory consent-decree activities.
• Experience with retrospective CAPA reviews and large-scale remediation programs.
• Experience with complaint handling, nonconformance, deviation, audit, or change-control systems.
• Familiarity with risk-management principles and ISO 14971.
• Experience preparing CAPA metrics, trend reports, and management-review materials.