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CAPA Quality Engineer

2 months ago

hyderabad, India Tek Support Full time

Position Overview :

We are seeking a highly skilled CAPA Quality Engineer to lead and manage the Corrective and Preventive Action (CAPA) process, ensuring compliance with regulatory standards and internal quality systems. The ideal candidate will oversee the identification, investigation, and resolution of quality issues, driving continuous improvement initiatives and ensuring regulatory audit readiness.


Key Responsibilities :

  • CAPA Leadership : Manage the entire CAPA process, from issue identification to resolution, ensuring timely investigation and implementation of corrective and preventive actions.
  • Root Cause & Risk Assessment : Facilitate root cause analysis using tools such as 5 Whys, Fishbone Diagrams, and Failure Mode and Effects Analysis (FMEA), ensuring thorough investigation and risk assessment.
  • Cross-Functional Collaboration : Work closely with R&D, Manufacturing, and Regulatory Affairs teams to ensure CAPA activities meet both quality and regulatory standards.
  • Regulatory Compliance : Ensure all CAPA documentation is compliant with regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820, as well as internal quality system procedures.
  • Continuous Improvement : Identify and address process gaps through CAPA outcomes, implementing corrective measures that lead to long-term quality improvements.
  • Data Analysis & Reporting : Perform data analysis and trend reporting for CAPA activities, ensuring the effectiveness of corrective actions and regulatory compliance.
  • Audit Support : Participate in internal and external audits, providing CAPA-related support and ensuring audit readiness.
  • Training & Development : Develop and maintain CAPA training materials and conduct process training for cross-functional teams to ensure compliance and understanding.
  • Effectiveness Monitoring : Monitor the implementation and effectiveness of corrective actions, ensuring long-term resolution and prevention of recurring quality issues.


Required Qualifications :

  • Experience : Proven experience managing CAPA processes within the medical device industry.
  • Regulatory Knowledge : Strong understanding of quality systems and regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820.
  • Root Cause Analysis & Risk Management : Expertise in using root cause analysis tools and conducting risk assessments.
  • Adaptability : Ability to thrive in a fast-paced environment and manage shifting priorities effectively.


Education :

  • Degree : Bachelor’s degree in Engineering, Life Sciences, or a related field is required.
  • Preferred : Advanced degree or certifications in Quality Engineering (CQE) or Six Sigma.


Top Skills :

  • Expertise in CAPA processes and regulatory compliance (ISO 13485, FDA 21 CFR Part 820).
  • Proficiency in root cause analysis and risk management tools such as 5 Whys, FMEA, and Fishbone Diagrams.
  • Experience with audit support and documentation management.