Fakhouri Yassa

QA Specialist at Medical Company
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Contact Information
us****@****om
(386) 825-5501
Location
UK
Languages
  • English Native or bilingual proficiency
  • German Native or bilingual proficiency

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Bio

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Credentials

  • Persuading & Influencing Training
    Need for Achievement
    Feb, 2016
    - Nov, 2024
  • Advanced Microsoft Excel 2013
    Activia Training Ltd
    Jan, 2015
    - Nov, 2024
  • Presentation Skills
    Need for Achievement
    Feb, 2014
    - Nov, 2024
  • ISO13485:2003 with ISO9001:2008 Lead Auditor for Medical Devices
    QCS International
    Dec, 2013
    - Nov, 2024

Experience

  • Medical Company
    • Medical Device
    • 200 - 300 Employee
    • QA Specialist
      • Sep 2017 - Present

      * Risk assessed complaints for EMEA region to determine Vigilance Report applicability. * Submitted reports to authorities and handled authority communications. * Provided gap analysis on procedures and updated quality documents. * Implemented various process improvements and organised face to face meetings with MHRA. * Risk assessed complaints for EMEA region to determine Vigilance Report applicability. * Submitted reports to authorities and handled authority communications. * Provided gap analysis on procedures and updated quality documents. * Implemented various process improvements and organised face to face meetings with MHRA.

  • Elekta
    • Sweden
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • RA & QA Engineer
      • Nov 2012 - Aug 2017

      * Manage several projects and work on Adverse Event & Recall Reporting * Design and maintain Global Post Market Surveillance websites using SharePoint * Responsible for auditing of complaint records and lead auditor certified ISO13485 * Work with diverse departments on metrics for Management Reviews and Competitor Analysis * Create reports in Salesforce (CRM) for external audits and senior management * Manage queries of authorities globally such as FDA, MHRA & BfArM * Participate in external and internal audits and create global procedures & policies

  • American Express
    • United States
    • Financial Services
    • 700 & Above Employee
    • Corporate New Accounts Analyst
      • Aug 2010 - Nov 2012

      * Work distribution, staff training and issuing of credit cards to clients of diverse companies * Responsible for resolving outstanding client issues and ensuring customer satisfaction * Undertook projects to handle vital clients and company critical issues * Work distribution, staff training and issuing of credit cards to clients of diverse companies * Responsible for resolving outstanding client issues and ensuring customer satisfaction * Undertook projects to handle vital clients and company critical issues

  • MEDICAL DEVICE DEVELOPMENT LIMITED
    • United Kingdom
    • Manufacturing
    • R&D Engineering Placement
      • Apr 2010 - May 2010

      * Created and tensile tested engineering material samples and product concept samples. Set the testing environment and designed the relevant jigs. * Analysed the test data by applying material science, stress strain analysis, charts and standard deviation. * Designed client products, engineering parts and assemblies for manufacture and animation using Alibre Design. * Created and tensile tested engineering material samples and product concept samples. Set the testing environment and designed the relevant jigs. * Analysed the test data by applying material science, stress strain analysis, charts and standard deviation. * Designed client products, engineering parts and assemblies for manufacture and animation using Alibre Design.

  • Rolls-Royce Motor Cars
    • United Kingdom
    • Retail Luxury Goods and Jewelry
    • 700 & Above Employee
    • Assembly Operative
      • Nov 2009 - Apr 2010

      * Responsible for Transfer Station including ordering specified car bodies from paint shop, lifting car body on equipment, paint checking, key coding, door removal and assigning car body to assembly line * Responsible for door preassembly including collecting relevant parts from door supermarket, ensuring continuous production and preparation of door panels, mirrors and veneer * Managed, quality checked and ordered stock in door area in collaboration with the line runner * Responsible for Transfer Station including ordering specified car bodies from paint shop, lifting car body on equipment, paint checking, key coding, door removal and assigning car body to assembly line * Responsible for door preassembly including collecting relevant parts from door supermarket, ensuring continuous production and preparation of door panels, mirrors and veneer * Managed, quality checked and ordered stock in door area in collaboration with the line runner

  • Deburring Centre Ltd
    • United Kingdom
    • 1 - 100 Employee
    • University of Brighton Major Project
      • Jul 2008 - Jun 2009

      * Researched the process parameters and efficiency of Thermal Explosion Machine by designing, conducting and analysing experiments * Identified and investigated areas within the company that could form the basis of future cost reduction programme e.g. downtime of employees, use of enhanced equipment, workflows and machine efficiency * Established a relationship between the University and the company, allowing the company to use the Universities research facilities such as the Electron Microscope

Education

  • University of Brighton
    BEng (Hons), Mechanical Engineering
    2005 - 2009

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