Ing. Aishwarya Gunasekaran

Bis 2019, Project Manager and Business intelligence, Cloud-R
Mailand, Italien

Fähigkeiten und Kenntnisse

Technical Writing report
Project Management
Quality System Mangement
ISO 13485
ISO 9001
ISO 14791
FDA Regulation
CE Regulation
Agile
User Story Mapping
GDPR
Data Analysis

Werdegang

Berufserfahrung von Aishwarya Gunasekaran

  • 7 Monate, Nov. 2018 - Mai 2019

    Project Manager and Business intelligence

    Cloud-R

    Developing database Epilepsy and Antiepileptic Drug during pregnancy. Informative highlighted Statistics for Patients database Dashboards, Annual Report Rare Disease, New changes made in database and Evaluation Report. Generating User Story Mapping based on Customer Requirements, Training and Practicing AGILE methodology.

  • 5 Monate, Apr. 2018 - Aug. 2018

    Quality Engineer

    Amiko.srl

    Controlling incoming components – Non conformance Report – FDA (10 blocks). Performed quality inspections and drafted reports to detail non-conforming material issues. Contributed to root cause analysis to determine core reason for failures and errors.

  • 3 Monate, Juli 2016 - Sep. 2016

    Quality Engineer

    Biotechware

    Coordinating and Assisting updating procedures in compliance to recently amended standards ISO 13485-2016, ISO 9001-2015, internal audit, Risk based approach. Research for additional incoming and in-process controls on components and sub assemblies in the cooperation with the supplier.

  • 1 Jahr und 3 Monate, Mai 2013 - Juli 2014

    Quality and Tender engineer

    Solokraft Indusrtries

    Worked with Government Doctors to understand requirements and provide exceptional service in a profit based manner. Monitoring and control of warranty failures and providing periodical service and maintenance of product installed. Product Demonstration. Tender documentation (technical).

  • 10 Monate, Juli 2012 - Apr. 2013

    Regulatory Engineer

    DyAnsys India Pvt.Ltd

    Quality Plan (Process control Plan, Process verification plan for product, Process Flow Chart, Traceability Plan, Traceability List for the components), Hardware Description, Software test case report, User manual for FDA and CE certification.Administrating company forum Doctor to Doctor Interaction and Remodeling website.

Ausbildung von Aishwarya Gunasekaran

  • 3 Jahre und 2 Monate, März 2016 - Apr. 2019

    Biomedical Engineering

    Politecnico di Milano

    Image Processing and Computer Aided surgery, Biomedical image processing and signal processing, Life Support, Biomedical Respiratory, Biomachines, Image Processing Laboratory, Health care management and Project Mangement

  • 4 Jahre, Juni 2008 - Mai 2012

    Biomedical Engineering

    Anna University, Chennai

    Image Processing, Signal Processing, tel medicine, Medical Physics, Biosensors, Neural Network, Digital Signal Processing, Medical Devices

Sprachen

  • Italienisch

    Gut

  • Deutsch

    Grundlagen

  • Englisch

    Fließend

  • Hindi

    -

  • Tamil

    -

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