Experience

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  Tata consultancy services

  Feb 2014 - Jul 2023

  Client-3M KCIMultiple project of Sustainable EngineeringWorked on creating Risk Management Plan, Risk Management Report, Technical Documentations for medical devicesWorked on review of RTMs and test reports, test protocols, PSURs and quality procedures.Knowledge of ISO-14971 and ISO-13485, Change Management Requests.MDR submission(3500A) for Level 2 and 3 devices, Vigilence reporting and Complaint handling and investigation for adverse and product problem Client - MedtronicRegulatory reporting/Medwatch submissions/Regulatory reporting decision Client- MedtronicPost Market Surveillance activities/Medical device complaint handling/investigation

  • Quality Assurance Engineer

    Jul 2019 - Jul 2023

  • Vigilance Reporting for Medical Device Client

    Aug 2017 - Jun 2019

  • Consumer Affairs/Post Market Surveillance

    Feb 2014 - Aug 2017
• 

  Alten india

  Jul 2023 - Jun 2024

  Senior engineer

  Writing Post Market Surveillance Plans, PMS Reports, Product Safety Update Report for Class I, II and III Medical devices specifically Spinal Implants and Instruments.Complaint investigation including risk Assessment and Device History ReviewReview of Risk files, Technical documentation, CERs and PMCFs.

• 

  Stryker

  Jul 2024 - now

  Staff engineer, post market surveillance