Job Summary:

We are seeking an experienced

CAPA Remediation Specialist to support the review, remediation, documentation, and closure of Corrective and Preventive Actions (CAPAs) within a regulated Quality Management System (QMS). The ideal candidate will have solid expertise in medical device quality systems, root cause investigations, CAPA effectiveness, and regulatory compliance.

Key Responsibilities:
Review and remediate open, overdue, and closed CAPA records for compliance and completeness.
Evaluate investigations, root cause analyses, risk assessments, and corrective/preventive action plans.
Apply root cause analysis tools such as

5-Why, Fishbone, and Fault Tree Analysis

.
Ensure CAPA actions are properly documented, traceable, measurable, and effective.
Review supporting documentation, including SOPs, validation records, training records, and investigation reports.
Verify linkage between CAPAs, complaints, nonconformances, deviations, audits, and other quality records.
Document remediation activities within the electronic Quality Management System (eQMS).
Support CAPA metrics, status reporting, audit readiness, and regulatory inspections.
Collaborate with Quality, Regulatory, Engineering, Manufacturing,



and other cross-functional teams to complete remediation activities on schedule.

Required Qualifications:
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
10+ years of experience in Quality Assurance, Quality Systems, CAPA, or compliance within the medical device industry.
Robust hands-on experience with CAPA investigations, remediation, and effectiveness verification.
Solid understanding of FDA Quality System Regulations,

ISO 13485

, and applicable medical device regulations.
Experience with electronic Quality Management Systems (eQMS).
Excellent analytical, technical writing, documentation, and problem-solving skills.
Robust communication skills with the ability to work independently and in cross-functional teams.

Preferred Qualifications:
Experience supporting FDA inspections, regulatory remediation, or audit readiness initiatives.
Experience with large-scale CAPA remediation programs and retrospective CAPA reviews.
Knowledge of complaint handling, deviations, nonconformances, change control, and audit systems.
Familiarity with

ISO 14971

risk management principles.
Experience preparing CAPA metrics, trend analysis, and management review reports.

📌 Capa Remediation Specialist Hyderabad
🏢 intellectt
📍 Hyderabad