Sheethal Vansraj

Experience

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  FLUTECH ENGINEERING PVT. LTD. - India

  Mar 2015 - Jan 2019

  Quality engineer
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  Wipro limited tarang

  Feb 2019 - Jun 2020

  Quality Co-ordinator

  • Responsible to follow the requirements of IEC/ISO 17025 and the roles and responsibilities as identified in the Quality Management System.• Ensure the testing activity is carried out as per the customer requirement and/or international standard requirements.• Key role in preparing and applying for IEC/ISO 17025 accreditation audit through NABL, A2LA audit.• Controls and maintains Quality and Testing team documents • Periodically performs the in-process inspection in all the labs to ensure all the quality system requirements, Customer requirements, and testing standard requirements are fulfilled.• Reviews the test reports on a sample basis and ensures the requirements are satisfied. If any non-conformance is identified, CAPA will be initiated to take necessary corrective action.• Performs risk-based analysis to prevent/reduce the potential failure. • Periodically reviews the repeated NC and checks the feasibility for Poko-yoke and implements to avoid the recurring problems like automation of system and updating the document templates, etc.• Verify the calibration certificate of all equipment for its Calibration Parameters, Range, Results, Deviation, and verdict, etc. and tracking it if there is an error or deviation. • Periodical review of the status of equipment calibration• Periodical review of the intermediate check report of equipment and ensure the equipment checked for the intended use. If there is any Non-conformance, action will be initiated.• Monitoring the validity of results under various criteria like alternate instrumentation, replicate & repeat test, different method, inter lab comparisons and ensuring the result validness.• Obtain customer feedback for all projects from the client and initiate action.• Verify the laboratory is fulfilling as per NABL 105 requirements on Environmental condition and other.• Conduct Internal Audit once in a year and ensure the system requirements are followed. Show less

• 

  Baxter R&D

  Jun 2020 - Feb 2025

  Senior Research And Development Engineer

  1. Serve as the primary contact for global change controls for assigned product families, assessing impacts, and maintaining Design History File (DHF) elements.2.Conduct risk management according to ISO 14971 and 13485 standards, ensuring thorough documentation and assessment for product changes and compliance with FDA and EU MDR regulations.3 Oversee the validation of test methods and execute proper verification processes, including developing and conducting Test Method Validation (TMV) for nonstandard methods.4 Develop and maintain the R&D testing lab in compliance with Quality Management System (QMS) requirements and ISO 13485 standards, including preparing for quality audits.5.Lead and perform Qualification (IQ, OQ, PQ, FAT, SAT) of lab equipment in compliance with 21 CFR Part 11, ensuring proper maintenance and calibration.6.Implement ALCOA+ and Good Documentation Practices (GDP) in lab documentation, and prepare comprehensive test protocols and reports, including statistical analyses.7.Coordinate with cross-functional teams on non-conformance investigations, new product development (NPD), and sustaining projects, ensuring lab requirements are met and resources are efficiently utilized. Show less

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  Vantive

  Feb 2025 - now

  Senior Research And Development Engineer

  1. Serve as the primary contact for global change controls for assigned product families, assessing impacts, and maintaining Design History File (DHF) elements.2.Conduct risk management according to ISO 14971 and 13485 standards, ensuring thorough documentation and assessment for product changes and compliance with FDA and EU MDR regulations.3 Oversee the validation of test methods and execute proper verification processes, including developing and conducting Test Method Validation (TMV) for nonstandard methods.4 Develop and maintain the R&D testing lab in compliance with Quality Management System (QMS) requirements and ISO 13485 standards, including preparing for quality audits.5.Lead and perform Qualification (IQ, OQ, PQ, FAT, SAT) of lab equipment in compliance with 21 CFR Part 11, ensuring proper maintenance and calibration.6.Implement ALCOA+ and Good Documentation Practices (GDP) in lab documentation, and prepare comprehensive test protocols and reports, including statistical analyses.7.Coordinate with cross-functional teams on non-conformance investigations, new product development (NPD), and sustaining projects, ensuring lab requirements are met and resources are efficiently utilized. Show less