Specialist II - Corrective and Preventive Actions

Summary

The CAPA Specialist is responsible for managing the Corrective and Preventive Action (CAPA) process to ensure compliance with global regulatory requirements and internal quality standards. This role supports cross-functional investigations, drives root cause analysis, and ensures timely and effective resolution of quality issues impacting product safety, performance, and compliance.

The CAPA Specialist will maintain proficiency in standards, regulations and guidance documents to provide continuing awareness on changing requirements and ensure compliance.

Responsibilities

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• Lead and manage CAPA investigations, ensuring thorough root cause analysis and effective corrective / preventive actions.
• Collaborate with cross-functional teams (R&D, Quality, Engineering, Manufacturing, Regulatory, Clinical) to resolve quality issues.
• Maintain CAPA documentation in compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR 2017 / 745.
• Monitor CAPA effectiveness and ensure timely closure of records.
• Prepare CAPA metrics and reports for management review and regulatory audits.
• Support internal and external audits, including MDSAP and Notified Body inspections.
• Train and mentor team members on CAPA processes and problem-solving methodologies (e.g., 5-Why, Fishbone, A3).
• Participate in continuous improvement initiatives related to quality systems and risk management.

Essential Functions of the Role

Work Experience Requirements

Education Requirements

Specialized Skills / Technical Knowledge

Local Specifications (English And Local Language)

Mode - Hybrid

Location - Gurugram

Skills Required

Iso 13485, Root Cause Analysis, Fmea, fault tree analysis, Capa