Santosh Palanichamy

Experience

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  Myoung Shin India Automotive Private Limited

  Jan 2011 - Nov 2013

  Maintaining Quality Standards, Auditing System and Process in compliance with IQMS, Presenting Quality Status to Top management, a member of TFT, Supplier Audit and Evaluation, Preparing Check sheets and standards, PPAP submission for 4M change, BIW Audit, CMM, SPC, Process Revalidation, AQL Monitoring, Cost Benefit Analysis, DMAIC Approach for Customer and Field complaints, GQMS Management, PPM Threshold, Quality Cost. Introduction to factory set up on production and process. Training on various shop floor segments including Heavy Press Shop (HPS), Body Shop, Paint Shop add Assembly. Observe counter measure preparation procedure and way of approach. Understand various welding techniques involved body assembly. CMM measurement for BIW. Observe audit trails and inspection. Assist in preparing work standard and inspection procedures.

  • Engineer QA

    Jan 2012 - Nov 2013

  • Graduate Engineering Trainee

    Jan 2011 - Dec 2011
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  Baxter International Inc.

  Nov 2013 - Jan 2022

  Technical - EU MDR Portfolio management for CE marked products under Renal Therapy. Overall planning and execution for the given products. Responsible and accountable for end to end program management to achieve MDR compliance. Act as a PM, drive team towards established milestones and delivery targets.Management - Status reporting, Program monitoring and tracking (Project Plan), evaluate current and foreseeable risk and initiate suitable mitigation plans to overcome those risk. Training and team development. Show less Technical - Design History File improvement and risk reduction. Requirements management and verification fulfillment. Standards assessment, applicability and compliance demonstrations. EU MDR Regulation program building support; develop checklist, support operations model establishment. Provide estimation and plans for task based on inputs available and expertise in the field of workManagement - Oversee a small team within program on daily task and progress. . Conduct performance review, discuss one on one with sub ordinates and facilitate skill improvisation. Recruitment and skill development through classroom training programs. Show less

  • Functional Lead (Consultant)

    Jul 2017 - Jan 2022

  • Plant Lead (Consultant)

    Jul 2015 - Jun 2017

  • Product Engineering Specialist (Consultant)

    Nov 2013 - Jun 2015
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  HCLTech

  Nov 2013 - Jan 2022

  Technical - EU MDR Portfolio management for CE marked products under Renal Therapy. Overall planning and execution for the given products. Responsible and accountable for end to end program management to achieve MDR compliance. Act as a PM, drive team towards established milestones and delivery targets.Management - Status reporting, Program monitoring and tracking (Project Plan), evaluate current and foreseeable risk and initiate suitable mitigation plans to overcome those risk. Training and team development. Show less Technical - Design History File improvement and risk reduction. Requirements management and verification fulfillment. Standards assessment, applicability and compliance demonstrations. EU MDR Regulation program building support; develop checklist, support operations model establishment. Provide estimation and plans for task based on inputs available and expertise in the field of workManagement - Oversee a small team within program on daily task and progress. . Conduct performance review, discuss one on one with sub ordinates and facilitate skill improvisation. Recruitment and skill development through classroom training programs. Show less

  • Technical Lead

    Oct 2019 - Jan 2022

  • Lead Engineer

    Jul 2016 - Sept 2019

  • Member Of Technical Staff

    Nov 2013 - Jun 2016
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  ISTAR Medical

  Feb 2022 - now

  Global Regulatory Affairs