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, corrective actions, and preventive measures.
• Investigate non-conformities, deviations, and complaints to identify underlying root causes.
• Analyze historical data, adverse events, and complaint trends to improve design, manufacturing, and post-market monitoring.
• Collaborate with cross-functional teams to implement effective corrective actions and reduce non-conformance risks.
• Maintain accurate CAPA records and present metrics, trends, and effectiveness reports to senior management.
• Support internal and external audits by providing required documentation and evidence of compliance.

Required Skills

• 4-6 years of experience in CAPA management, quality assurance, or regulatory compliance.
• Deep understanding of medical device regulations (21 CFR Part 820), pharmaceuticals (21 CFR Part 210/211), and ISO 13485.
• Proficiency with root cause analysis tools such as 5-Whys, Fishbone Diagrams, and FMEA.
• Experience working within Good Manufacturing Practices (GMP) environments.
• Familiarity with risk management software and CAPA management systems.
• Bachelor’s degree in Engineering, Quality, or Life Sciences related areas.

Key Skills

Education

Any Gradute