Midhun Jose

Midhun Jose

Process Engineer

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location of Midhun JoseBengaluru, Karnataka, India

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  • Timeline

  • Skills

    Autocad
    Lean manufacturing
    Mechanical engineering
    Microsoft office
    Pro engineer
    Six sigma
    5s
    Ptc creo
    Manufacturing processes
    Verification
    Validation
    Quality system
    Mrb
    Solidworks
    Root cause analysis
    Plc
    Process engineering
    Microsoft excel
    Automation
    Manufacturing engineering
    Fda
    Iso 13485
    Fmea
    Medical devices
    Quality assurance
    Quality management
    Minitab
  • About me

    Auditor with vast experience in electromedical devices domain. Lead auditor for ISO 13485 and 9001. Performing project planning for technical file review and quality management system audit. Assess technical files against European directives. Previously experienced Process Engineer with a demonstrated history of working in the electrical and electronic manufacturing industry. Skilled in AutoCAD, and PTC Creo. Professional with a Degree focused in Mechanical Engineering from Manipal Institute of Technology.

  • Education

    • Manipal Institute of Technology

      2010 - 2013
      Degree Mechanical Engineering

      Activities and Societies: Robomanipal Mechanical

    • NTTF

      2006 - 2009
      Diploma Mechatronics, Robotics, and Automation Engineering

      Diploma in Mechatronics

  • Experience

    • GE HealthCare

      Nov 2013 - Apr 2015
      Process Engineer

      Process Engineer for Vascular and MR subsystems

    • Flex

      Apr 2015 - Aug 2017
      Process Engineer

      Process engineer for medical products

    • Zenith Quality Assessors Pvt. Ltd.

      Sept 2017 - Aug 2019
      QMS Auditor and Product Assessor

      QMS audit and product certification as per 93/42 EEC for medical devices.

    • HCLTech

      Sept 2019 - May 2023
      • Lead- Regulatory Affairs

        Sept 2022 - May 2023
      • Senior Regulatory Affairs Specialist

        Sept 2019 - Sept 2022
    • Siemens Healthineers

      May 2023 - now
      Medical Device Auditor- SaMD
  • Licenses & Certifications