David Burke

Medical Device Certification and Inspection Officer at National Standards Authority of Ireland
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Contact Information
us****@****om
(386) 825-5501
Location
Galway Metropolitan Area, IE
Languages
  • German -
Skills

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Credentials

  • Certified professional for medical software
    ICPMSB
    Dec, 2021
    - Nov, 2024
  • Lead auditor iso 13485
    IRCA | International Register of Certificated Auditors

Experience

  • National Standards Authority of Ireland
    • Ireland
    • International Trade and Development
    • 100 - 200 Employee
    • Medical Device Certification and Inspection Officer
      • Jul 2019 - Present

      Product Certification SAMD, MDR and MDD product reviews and audits. Team NB member. Product Certification SAMD, MDR and MDD product reviews and audits. Team NB member.

  • Boston Scientific
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Design Assurance Engineer II, Mechanical test Laboratory
      • Sep 2017 - Jul 2019

    • Research and Development/Quality Technician III
      • Oct 2015 - Jul 2019

    • Design Assurance Technician
      • Jun 2013 - Jun 2019

    • Design Assurance Quality Engineer (Development assignment)
      • Feb 2012 - Jun 2013

      IQ/OQ Equipment Validation, Equipment maintenance, Report /Protocol writing, Quality Audits. New product development activities. Mechanical Testing

    • Design Assurance Technician
      • Jun 2007 - Feb 2012

  • Connaught electronics Ltd
    • Tuam
    • Quality Analyst
      • Sep 2006 - Jul 2007

      cost of Quality calculations. BOM updates and Processing. Engineering change orders for Production BOMs, Customer Quality Co ordinator Voice of Customer for BMW/Mercedes Benz/ Toyota/ Bentley/ Jaguar/ Rolls Royce.Saab PSG and Land Rover. Generation and presentation of Quality Dept metrics at management meetings, RHoS Compliance project. cost of Quality calculations. BOM updates and Processing. Engineering change orders for Production BOMs, Customer Quality Co ordinator Voice of Customer for BMW/Mercedes Benz/ Toyota/ Bentley/ Jaguar/ Rolls Royce.Saab PSG and Land Rover. Generation and presentation of Quality Dept metrics at management meetings, RHoS Compliance project.

  • Various Schools
    • Secondary School Teacher
      • Jun 2004 - Dec 2006

      Taught Biology, Physics,Mathematics and Science Taught Biology, Physics,Mathematics and Science

Education

  • National University of Ireland, Galway
    Post grad Higher Diploma in quality Assurance, Ops Management, Quality Assurance, Statistical Quality control, Reliability and Maintenance, SQA
    2006 - 2007
  • National University of Ireland Maynooth
    BSc Hons, Biology, Mathematics, Physics, Computer Science
    1998 - 2003
  • University College Dublin
    H Dip Ed, Education
    2004 - 2005
  • IRCA
    Cert, ISO internal auditor
  • IRCA
    Cert, Lead Quality Auditor
  • Maynooth University
    Bachelor of Science (BSc), Biology, Physics, Mathematics, Computer Science
    1998 - 2003
  • National University of Ireland, Galway
    Postgraduate Degree, Computer Software Engineering

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