Mohandass Kannan

Quality Assurance Manager at Straits Orthopaedics (Mfg) Sdn Bhd
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Contact Information
us****@****om
(386) 825-5501
Location
Penang, Malaysia, MY

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Credentials

  • Packaging experimental training
    Oliver Healthcare Packaging
    May, 2022
    - Oct, 2024
  • Certified Internal Auditor (CIA)
    BSI
    Jul, 2020
    - Oct, 2024
  • ISO 14971:2019 Risk Management for Medical Devices
    BSI
    Jul, 2020
    - Oct, 2024
  • ISO13485:2016 Quality Management System
    Association of Malaysian Medical Industries (AMMI)
    Mar, 2019
    - Oct, 2024
  • Awareness Training on 21CFR Part 820
    TÜV SÜD
    Nov, 2018
    - Oct, 2024
  • Awareness training on GHTF Guidance on GHTF/SG3/N99-10:2004
    TÜV SÜD
    May, 2018
    - Oct, 2024
  • ISO9001:2015 Interpretation and Application
    BSI Neville Clarke – A BSI Professional Services Company
    Mar, 2018
    - Oct, 2024
  • ETO Sterilization -ISO11135-1:2014
    STERIS
    Apr, 2017
    - Oct, 2024
  • Gamma Sterilisation Training - ISO11137-1:2006
    STERIS
    Apr, 2017
    - Oct, 2024
  • Six Sigma Black Belt
    Indian Institute of Statistical science
    Jun, 2011
    - Oct, 2024

Experience

  • Straits Orthopaedics (Mfg) Sdn Bhd
    • Medical Device
    • 200 - 300 Employee
    • Quality Assurance Manager
      • Oct 2014 - Present

      Company is certified to ISO13485:2016,ISO9001;2015,FDA. Quality Head and QMR of Sterile and Non-Sterile Packaging of Medical Devices, Sterilization & Surface Treatment. Company is certified to ISO13485:2016,ISO9001;2015,FDA. Quality Head and QMR of Sterile and Non-Sterile Packaging of Medical Devices, Sterilization & Surface Treatment.

  • Dynamic Techno Medicals
    • India
    • Medical Device
    • 100 - 200 Employee
    • Quality Assurance Manager
      • Jul 2006 - Sep 2014

      Company is certified to ISO13485,ISO9001 Implementing, Monitoring and maintaining Quality system requirements for Semi permeable adhesive dressings. Monitor and Maintain the clean room requirements of Class 10K and 100K as per the international standard. Support Quality Management Representative functions to comply ISO and CE requirements Company is certified to ISO13485,ISO9001 Implementing, Monitoring and maintaining Quality system requirements for Semi permeable adhesive dressings. Monitor and Maintain the clean room requirements of Class 10K and 100K as per the international standard. Support Quality Management Representative functions to comply ISO and CE requirements

  • FUTURA MEDICALS (P) LTD (Subsidiary of HYPO GUARD INC,USA)
    • Kerala, India
    • Quality Assurance Officer
      • Sep 1998 - Jun 2006

      •Monitoring 100K Clean rooms •Monitoring and verifying In-coming, In-process and Finished goods inspection •Monitoring and analyzing process line •Define, develop, plan, create, execute, and manage validations (IQ/OQ/PQ) •Perform Internal and Vendor audit as per ISO and CE requirements. •Supported in Post market surveillance and complaint handling for PMS activities •Monitoring CAPA and follow ups for closure. •Monitoring 100K Clean rooms •Monitoring and verifying In-coming, In-process and Finished goods inspection •Monitoring and analyzing process line •Define, develop, plan, create, execute, and manage validations (IQ/OQ/PQ) •Perform Internal and Vendor audit as per ISO and CE requirements. •Supported in Post market surveillance and complaint handling for PMS activities •Monitoring CAPA and follow ups for closure.

Education

  • Mahatma Gandhi University, Kerala, India
    Master of Business Administration - MBA, Marketing and Human Resources Development
    2007 - 2009
  • Sikkim Manipal University of Health, Medical and Technological Sciences
    Master's degree, Total Quality Management
    2004 - 2006
  • Bharathidasan University, Tiruchirappalli
    Post Graduate Diploma in computer Application, Computer Application
    1996 - 1997
  • Bharathidasan University, Tiruchirappalli
    Bachelor of Science - BSc, Chemistry
    1990 - 1993

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