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Ian Carter

Ian Carter

Quality Engineer

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location of Ian CarterBrighton East, Victoria, Australia

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  • Timeline

  • About me

    Quality Manager at Leica Biosystems

  • Education

    • Abingdon & Witney College

      1992 - 1994
      BTEC National Diploma in Engineering Manufacturing Engineering DMM

      General Engineering National Diploma with German exchange (additional language module).

    • Larkmead Secondary

      1986 - 1992

    • Loughborough University

      1994 - 1998
      Bachelor of Engineering (BEng) Product Design & Manufacturing

      B.Eng (Hons) Product Design & Manufacturing.Industrial Studies inc a year working at Raychem/Tyco.

  • Experience

    • Toyota Motor Manufacturing UK

      Sept 1998 - Feb 2003
      Quality Engineer

      Manufacturing quality support.

    • Toyota Motor Europe

      Feb 2003 - Feb 2008
      Senior Quality Engineer

      European manufacturing plant Materials Quality support.Global and European procedure development.Supplier quality and auditing.

    • Rolls-Royce

      Feb 2008 - Apr 2010
      Supplier Quality Engineer

      Supplier Quality Engineer for the Fuel Cells team, followed by the Submarine teams.

    • Fisher & Paykel Healthcare

      May 2010 - Nov 2019
      Global QMS Process Manager

      Managing 21 CFR 820 and ISO 13485 compliant global QMS procedures including Auditing, CAPA & Management Review. Implementing ISO 13485:2016 and the new EU Medical Device Regulations into the global QMS and introduced MDSAP auditing activity in 2016.Certified Lead Auditor for ISO 13485: 2016.Support and train Quality activities including failure investigation, change control, risk management.Medical Device Design, Manufacturing & Regulatory support.

    • Leica Biosystems

      Nov 2019 - now
      Quality Manage

  • Licenses & Certifications

    • Lead Auditor ISO13485:2016

      BSI