Sai Raja D
Summary
As a seasoned Senior Quality Engineer in medical devices manufacturing, 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.
Overview
6
6
years of professional experience
2
2
Certification
Work History
Senior Quality Assurance Engineer
Imeds Global Pvt Ltd
01.2022 - Current
- Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
- Supporting Product Development teams (Development, testing) for each release in documentation and Release management & had experience working in a cross-functional team environment.
- Maintaining QMS and being responsible for the overall quality of the process and oversee the management and compliance with the procedures, policies, and technologies associated with the process.
- Led the team in regulatory submissions for test license & manufacturing license of Skin staplers, Staple Remover, Oxygen concentrator, CPAP, Bipap, Ventilator to regulatory authorities (CDSCO).
- Collaborated with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA,PFMEA and risk management report, adhering to ISO 14971:2019 standards .
- Ensuring compliance with Quality System Regulations, EU-MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.
- Preparing & Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements.
- Preparing the Quality Procedures, Quality Manual for smooth functional operation of the various independent departments.
- Preparing Stability Studies Protocol & Reports as per ICH guidelines of Stability Testing of new Drug Substances and Products.
- Providing Quality support to facilitate resolution of product complaints and/or safety issues.
- Prepared Process Protocol documents for the Class B medical devices.
- Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
- Evaluate verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures.
- Lead the team in ISO 13486:2016 and in manufacturing license audits.
Service Engineer
Air Liquide Medical Systems Pvt Ltd
03.2021 - 12.2021
- Installation and Servicing of Ventilators
- Performs PM procedures using manufacturer's recommendations, standards or code requirements, as well as industry acceptable processes as guidelines
- Strong customer service communications skills to interact with hospital personnel and vendors to achieve positive outcomes
- Safely and effectively uses test equipment to verify clinical equipment function, performance, safety testing and troubleshooting
- Performs minor technical repairs as necessary
- Conducts output/ performance testing, calibration and electrical safety testing
- Travelling to Sites for the Servicing of Medical Equipment's as per the Breakdown.
Technical Service Engineer
Trimed Solutions India Pvt Solutions
05.2018 - 02.2021
- Preparing the Calibration/Testing or Working Procedures for the calibration/Testing of Various Medical Devices, Laboratory Equipment and Diagnostic radiology Equipment's
- Reviewed and analyzed functional test results for the repaired equipment
- Installation and Servicing of medical Equipment's such as Patient Monitor, ECG Machine, Syringe & Infusion Pump, Monitor, OT Table, Ventilators, Cautery Machine, Lab Analyzers, Anesthesia Work Station, Centrifuge, Radiant Warmers, Defibrillator, OT lights
- Conducting and performing the Preventive Maintenance and Calibration Schedule
- Travelling to Sites for the Servicing/Calibration of Medical Equipment's.
Education
M-tech in Quality Management - Quality Management
Bits Pilani
Hyderabad05.2024
Bachelor of Technology (Electronics & Instrumentation) - Electronics & Instrumentation
VNR Vignana Jyothi Institute Of Eng. & Technology
05.2018
Diploma (Electronics And Instrumentation) - Electronics And Instrumentation
Govt Polytechnic Bellampalli
05.2015
Secondary School Certificate -
Fatima Convent High School
05.2012
Skills
- Functional Testing
- Six Sigma Methodologies
- Quality Management Systems
- Documentation Review
- SOP Writing
- Audit Coordination
- Process Improvement Methodologies
- Failure Mode and Effects Analysis (FMEA)
- Fish-bone Analysis
- Pareto Analysis
Certification
- 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.
Personal Information
- Age: 26 years
- Father's Name: Donga Nageshwar Rao
- Mother's Name: Donga Nagamani
- Date of Birth: 11/22/96
- Nationality: Indian
- Marital Status: Single
Disclaimer
I hereby declare, to the best of my knowledge and belief, that the given above are true.
Languages
English
Upper intermediate (B2)
Hindi
Upper intermediate (B2)
Telugu
Advanced (C1)
Timeline
Senior Quality Assurance Engineer
Imeds Global Pvt Ltd
01.2022 - Current
Service Engineer
Air Liquide Medical Systems Pvt Ltd
03.2021 - 12.2021
Technical Service Engineer
Trimed Solutions India Pvt Solutions
05.2018 - 02.2021
M-tech in Quality Management - Quality Management
Bits Pilani
Bachelor of Technology (Electronics & Instrumentation) - Electronics & Instrumentation
VNR Vignana Jyothi Institute Of Eng. & Technology
Diploma (Electronics And Instrumentation) - Electronics And Instrumentation
Govt Polytechnic Bellampalli
Secondary School Certificate -
Fatima Convent High School
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