Description

You will manage the end-to-end corrective and preventive action (CAPA) process to ensure regulatory compliance and product quality.

Responsibilities

• Manage the full CAPA lifecycle, including root cause analysis, implementation of corrective actions, and preventive measures.
• Investigate non-conformities, deviations, and complaints to identify root causes and systemic issues.
• Analyze historical data, adverse events, and complaint trends to drive improvements in design, manufacturing, or post-market monitoring.
• Maintain accurate CAPA documentation and present effectiveness reports and metrics to senior management.
• Support internal and external audits by providing necessary records and evidence of compliance.
• Conduct training on CAPA procedures and best practices for cross-functional teams.

Required Skills

• Bachelor’s degree in Engineering, Quality, or Life Sciences.
• 4-6 years of experience in CAPA management, quality assurance, or regulatory compliance.
• Strong knowledge of root cause analysis tools including Fishbone Diagram, 5-Whys, and FMEA.
• Deep understanding of 21 CFR Part 820, 21 CFR Part 210/211, and ISO 13485.
• Experience with risk management software and CAPA management systems.
• Proficiency in CAPA management and risk management methodologies.

Key Skills

Education

Bachelor's degree