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Spurti Kesti

Spurti Kesti

Senior Software Quality Assurance Engineer at BD

Bengaluru, Karnataka

- Seasoned Biomedical professional with 7 years of experience in Design and Development across multiple globally renowned medical device manufacturing companies.
- Hands-on working knowledge of Medical Devices such as Patient Monitors, Continuous Glucose Monitor and Haemodialysis System, and theoretical domain knowledge on few other medical devices.
- Completed FDA, CB, UL safety certification processes for two patient monitors.
- Well versed with Medical Device - Quality Management Systems as per ISO 13485.
- Basic knowledge about IEC 60601-1, IEC 60601-1-2, IEC 60601-6, IEC 60601-8, ISO 14971, IEC 62366, IEC 60601-2-27, IEC 80601-2-30, ISO 80601-2-61.
- Acquainted with Medical device Software Development Life Cycle(SDLC) processes as per IEC 62304.
- Proven product development knowledge in Patient Monitoring Systems which includes Quality and Regulatory requirements.
- Responsible for Computerized System Validation (CSV) of the tools being used for software development & testing project.
- Knowledgeable in 21 CFR PART 11 requirements and GAMP 5.
- Experienced in authoring/reviewing of Installation, Operational & Performance Qualification test protocols and reports.
- Worked on Requirement gathering and analysis.
- Capable of authoring the use cases and other technical specification documents required for implementation.
- Proven technical communication, logical reasoning, and problem solving skills.
- Completed various projects under project management methodologies such as V-model, Waterfall & Agile.


Experience:

  • Senior System Engineer (Medtronic)
  • Senior Engineer, Design & Development (Skanray Technologies, Healthcare Division)
  • Associate Consultant (Wipro Limited)
  • Senior Software Quality Assurance Engineer (BD)
  • IT Analyst (Tata Consultancy Services)

Skills:

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