Quality and CAPA

4 days ago


Pune, Maharashtra, India Cyient Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Roles and Responsibilities

  • Lead and manage CAPA process from initiation to closure.
  • Coordinate root cause investigations and ensure robust corrective actions.
  • Track and report CAPA metrics and trends to management.
  • Drive quality improvement projects and cross-functional collaboration.
  • Ensure timely documentation and regulatory compliance.
  • Facilitate audits and provide CAPA-related evidence.
  • Support risk management and preventive action initiatives.

Qualifications

  • Bachelor's degree in Engineering, Mechanical or related field.
  • 7+ years' experience in Quality/Regulatory in the medical device industry.
  • Strong knowledge of ISO 13485, 21 CFR 820, EU MDR, and risk management (ISO
  • Project management skills (PMP, CAPM preferred).
  • Excellent communication, facilitation, and problem-solving skills.

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