SAI RAJA

As a Quality Assurance Engineer bringing 6 years of experience in medical devices, I bring a wealth of expertise in ensuring adherence to regulatory standards, optimizing production processes, and driving continuous improvement initiatives. With a strong foundation in quality management systems, I excel in implementing robust quality control measures throughout the product lifecycle, from design and development to manufacturing and distribution. My proficiency extends to conducting thorough risk assessments, root cause analyses, and validation protocols to mitigate potential hazards and enhance product safety. I am adept at collaborating cross-functionally with engineering, manufacturing, and regulatory affairs teams to resolve quality issues efficiently while maintaining compliance with MDR and ISO regulations.

• Certified in "ISO 14971:2019 Medical devices — Application of risk management to medical devices".
• Certified in "Lean Six Sigma Green Belt".
• Certified and trained in "Internal Auditor Training on ISO 13485:2016 Medical Devices - Quality Management System."
• Certified and trained by the "Rigel Medical Systems on Biomedical Master Test Equipment" for handling and Maintenance.
• Certified in "Calibration Process of Biomedical Instruments" conducted by Oregon Healthcare Pvt Ltd, Kochi.

• Age: 27 years
• Father's Name: Donga Nageshwar Rao
• Mother's Name: Donga Nagamani
• Date of Birth: 11/22/96
• Nationality: Indian
• Marital Status: Single

I hereby declare, to the best of my knowledge and belief, that the given above are true.