VENKATESWARAN PALANISAMY

Experience

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  HCL Technologies

  Sept 2019 - May 2024

  * Contributing in risk analysis, estimation, and evaluation for use and design failures* Identifying options and feasible risk control measurements for failures* Remediation of DHF and risk management files for acquired products* Driving product changes and new market launches through change management* Conducting kickoff meetings and design review meetings for product changes* Evaluating DHF, driving identified tasks and managing cross functional team for product change implementation* Updating DHF elements against the sustenance changes* Assisting regulatory function by preparing, organizing and providing submission documents* Controlling of SOPs, specifications, verification, and validation documents* Creating design verification/validation and test method validation deliverables* Performing MDR remediation in DHF & Labeling, and creating remediation deliverables* Owning Non-Conformance (NC) and Corrective Action and Preventive action (CAPA)* Conducting initial assessment on Non-Conformance for its significance* Coordinating the investigation of root cause using Quality tools such as DMIAC and Fishbone diagram, 5 Whys* Establishing effectiveness criteria and driving implementation of CAPA identified* Conducting internal QMS audits* Leading a team of 10 members to accomplish project goals, foster collaboration and drive results Show less

  • Lead Engineer

    Jul 2022 - May 2024

  • Member Technical Staff

    Sept 2019 - Jun 2022
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  Phillips Medisize

  May 2024 - now

  Senior Risk and Reliability Engineer