CAPA Engineer | 2 to 4 years | Coimbatore

Job Description

Seeking a detail-oriented and proactive CAPA Engineer / Specialist to lead and manage Corrective and Preventive Action (CAPA) processes across product and process quality systems. The ideal candidate will be responsible for driving CAPA investigations from issue identification through implementation and effectiveness monitoring, ensuring compliance with global quality standards and regulatory requirements.

Key Responsibilities:

• Lead and facilitate CAPA investigations from initiation to closure, ensuring timely and effective resolution.
• Conduct root cause analysis using tools such as 5 Whys, Fishbone, 8D, DMAIC, and FMEA.
• Collaborate with cross-functional teams to define and implement corrective and preventive actions.
• Ensure CAPA documentation meets internal quality standards and regulatory requirements.
• Represent CAPA records during audits, inspections, and CAPA Review Board meetings.
• Monitor CAPA effectiveness and track metrics to drive continuous improvement.
• Apply statistical techniques and data analysis to identify trends and potential non-conformances.
• Ensure compliance with 21 CFR Parts 803, 806, 820, ISO 13485, ISO 9001, and ISO 14971.

Required Skills & Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).
• Minimum 5 years of experience in quality assurance, regulatory compliance, or CAPA management in a regulated industry (e.g., medical devices, pharma, manufacturing).
• Strong knowledge of CAPA systems, quality tools, and problem-solving methodologies.
• Excellent technical writing, documentation, and communication skills.
• Experience working in matrix organizations and facilitating cross-functional teams.

Preferred Qualifications:

• Certified in Lean Six Sigma, Quality Engineering, or Regulatory Affairs.
• Experience with electronic quality management systems (eQMS).
• Familiarity with metrology, risk management, and product lifecycle management.