MUGESH KUMAR THANASEKARAN

Experience

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  YTY INDUSTRY SDN. BHD.

  Oct 2017 - Dec 2017

  Industrial Trainee

  Assigned in research and development department. The job scope was fabricate new experiment, involved in their research project, production technical support, compounding method, manufacturing processing and glove defects analysis.

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  Hartalega

  Nov 2019 - Jun 2022

  Quality Assurance Engineer

  • Check and identify any deviations in procedure and work instruction against actual practicein the QAI section.• Investigate, address quality problem and/ or report to superior on any non-compliancefound during QAI sampling.• Communication with production and packing in regard to improvement on operationalissues.• To oversee the laboratory activities by ensuring that quality system established are beingimplemented successfully as per on AQL set forth (testing method, regulatoryrequirement, ISO documentation).• Provide training and guide subordinates to daily activates and identified training needs. • Conduct training evaluation for more than 50 group leader and 30 supervisor on a timelymanner.• Viewing of QAI reports to ensure its accuracy and that it is updates.• Involved internal and external audit across department and company.• Handle and involved in product qualification by customer for new launched surgical glove. • Handling in validation process, CAPA, FMEA and 7QC tools• Involved in many improvements project such man reduction and process improvementproject in QA area.• Chair and lead entire QAI and production meetings across department and management • Experienced in surgical product with product qualification and cleanroom (Class 10)handling.• Ensure safety and monitor the performance, attendance and discipline of subordinateswith assistance of supervisors. Show less

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  BD

  Jul 2022 - Nov 2023

  Senior QA Specialist (Customer Complaint)

  • Review of Life Science service complaint/non-complaint cases and work orders for theNorth America (NA) region (the any deviations in procedure and work instruction against actual practice in the orders for the NA region and the end-to-end complaint management process in the GA region.• Represent in Asia Pacific Regional Complaint Center (AP RCC) in cross-functional meetings/discussions relating to the end-to-end complaint management process as assigned• Support AP RCC Team Lead in monitoring the AP RCC Operational Metrics/Service Level Agreement (SLA) performance and ensure that the operational objectives and service level performance targets are consistently met.• Pioneer of the SaleForce and Trackwise North America complaint & intake management transition to AP region.• Main trainer for new hire and the outside parties on the process and workflow of complaint management and etc..• Handle and manage the internal auditing process and also become an auditor for job function and associate in the team.• Collaborate with Business/Country/Function Leaders on customer complaints to ensure business objectives are met.• Initiate, track, follow-up, and close Corrective and Preventive Actions.• Involved as main lead for projects such as transition project & data dashboard.• Ensure the strong ramp-up in the transition within the target deadline and associatedtargets are consistently met. Show less

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  Edwards Lifesciences

  Dec 2023 - Nov 2024

  Commercial Quality Engineer P2

  1. Assess technical/Trouble service center quality and compliance level. Providerecommendations and drive appropriate actions including but not limited to,escalation through the Non-conformance, CAPA and PRA processes.2. Review and approve the Validation Plan/documentation as Quality Engineer.Approver of Calibration/ Maintenance plan in Maximo as SQE. Change leader ofTrouble Shooting RBM.3. Assess the readiness of facility, processes, and people qualification from qualitycompliance for new product launch.4. Partner with FCA coordinator to execute FCA related to TSC.5. Support the tech service team in the identification, development and execution ofcontinuous improvement projects ensuring global standardization and compliance.6. Manage technical service project quality activities with the accountability forsuccessful completion of all deliverables to the business within established schedule,scope and quality objectives.7. Partner with cross functional groups to identify risks, develop mitigation strategies,alternative solutions, resolve issues, action item follow up.8. Supplier File Management SQMS/EQMS, Supplier Review Board, Supplier Auditcoordinator for APAC.9. Internal audit coordinator, File management, trending, tracking of audits and itsrelated action plans. Show less

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  Ansell

  Oct 2024 - now

  Associate Quality Assurance Manager

  • Support Head of QARA to review, monitor and recommend improvement to the Company's Quality Management System (which includes controls and documentation procedures)•Oversee the Quality Assurance (QA) operations team, including the QA executives and engineers.• Study and implement various sections of the quality assurance program. Evaluate and ensure customer requirement is met, approve release of products to customer and prior to packing, ensure sufficient control of non-conform goods, etc. relating to quality and monitor supplier quality management and process validation • Ensure and manage QA Executive/Engineer monitor and report on the production gloves daily performance to ensure its quality consistency and monitor/oversee SPC performance • Collate, study and analyze performance data pertaining to gloves quality ensuring compliance to sets target and standards. Endorse product release upon verifying all information on the COAs, inspections are accurate and meeting specification• Provide direct support to production on quality issue and trouble-shooting. Ensuring control on non-conforming gloves, anticipates program to release problems and takes corrective action (CAPA) and RCA by using 7 QC tools• Provide guidance to Lab Executive in daily Lab activities and checking to ensure within performance specification. Act on any out of specification by following the procedure and address quality issue timely and monitor incoming material inspection and taking corrective action if any quality issue by using SCAR system• Assist Head of QARA in ensuring compliance to regulatory and legislative requirements pertaining to Quality System and products. Also ensuring the implementation and provide guidance in risk management system, QFD, PRA/DURA and FMEA.• Handling and oversee plant complaint management system and investigation team Show less