Quality Engineer

1 month ago

Hyderabad, India Tek Support Full time

Job Responsibilities: We are seeking a dedicated CAPA Quality Engineer to lead and manage the Corrective and Preventive Action (CAPA) process, ensuring effective identification, investigation, and resolution of quality issues within our organization. As a CAPA Quality Engineer, you will collaborate closely with cross-functional teams to uphold regulatory compliance and drive continuous improvement initiatives based on CAPA outcomes.


  • Lead and manage the Corrective and Preventive Action (CAPA) process, ensuring timely identification, investigation, and resolution of issues.
  • Facilitate root cause analysis and risk assessment using tools such as 5 Whys, Fishbone Diagrams, and Failure Mode and Effects Analysis (FMEA).
  • Collaborate with cross-functional teams including R&D, manufacturing, and regulatory departments to ensure CAPA activities meet quality and regulatory requirements.
  • Ensure all CAPA documentation complies with regulatory standards (ISO 13485, FDA 21 CFR Part 820) and internal quality systems.
  • Drive continuous improvement initiatives based on CAPA outcomes, identifying process gaps and implementing effective corrective measures.
  • Perform data analysis and trend reporting for CAPA-related activities to ensure effectiveness and regulatory compliance.
  • Participate in internal and external audits, supporting CAPA-related inquiries and ensuring audit readiness.
  • Develop and maintain training materials and conduct CAPA process training for cross-functional teams.
  • Monitor the implementation and effectiveness of corrective actions to ensure long-term resolution of quality issues.


Qualifications:

  • Proven experience with CAPA processes in the medical device industry.
  • Strong understanding of quality systems and regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820.
  • Experience in root cause analysis, risk management, and quality improvement tools.
  • Ability to work in a fast-paced environment and adapt to shifting priorities.


Education:

  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • Advanced degree or certifications in quality engineering (CQE, Six Sigma) is a plus.


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 (5 Whys, FMEA, Fishbone Diagrams).
  • Experience with audit support and documentation management.

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