Kavithesh J K

Experience

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  Federal-Mogul Powertrain

  Aug 2016 - Dec 2017

  Quality Assurance Quality Control Engineer

  - Perform Physical inspection of Set-Up approval & Online inspection.- Maintained and Organized all Quality reports, Performing Gauge R and R, Writing Report

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  Zenith Precision Inc.

  Jan 2018 - Apr 2021

  Quality Assurance Engineer

  - Schedule and Chair Management Review Meetings - Worked with individual departments to help themcreate process documentation that complies with the company's standards.- Determine, document, and maintain QA systems: QA Manual, QSPs, Work Instructions, forms as perAS9100D, -Monitor, maintain and improve reporting customer metrics.- Preparing and Reviewing First Article Inspection report as per AS9102B,- Performed Internal Audit for cross-functional team and Supplier-Audit as per AS9100D,- Handling Customer complaint and Preparing 8D report.-Also participating in MRB meeting Show less

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  AUSA medical devices Pvt. Ltd.

  May 2021 - Dec 2021

  Quality Assurance Engineer

  - Knowledge on ISO 13485.- Responsible for documents such as Standard Operating Procedures / Work instructions for each process.- Responsible for Reviewing and approving the test protocol and Test report for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) - Create and Maintaining Device History Record (DHR) and its supporting records as per FDA 21 CFR 820.- Responsible for product qualification documents ( PFC , PFMEA , CP , SPC and MSA )- Experience in root cause and risk - assessment tools (FMEA, fish bone, etc.)- Preparation and Review of In-Process, Final Inspection Report and Certificate of Conformance. Show less

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  Christain Horta Design and Manufacturing Private limited

  Jan 2022 - Aug 2023

  Sr. Associate - Quality Assurance

  - Part of Design and R & D team to check and develop the product feasibility. - Leading CFT on counter measure preparation & analysis of all Quality issues using 7 QC tools (Fish Bone diagram ) and Risk assessment tools (PFMEA ) and 8D methodologies. - Responsible for Process Validation, Fixture Validation and taking required actions to meet requirements. - Daily Rejection analysis by Studying Non-conformities, Handling Disposition of NC products through Scrap Report. - Preparing and Reviewing Process Flow Chart, Work Instructions related to Quality function. Show less

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  Cyient DLM Limited

  Nov 2023 - now

  Senior Engineer-Quality