Laura Donizetti

Process & Improvement Manager at Fitesa
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Contact Information
us****@****om
(386) 825-5501
Location
Lecco, Lombardy, Italy, IT
Languages
  • Italiano Native or bilingual proficiency
  • Inglese Professional working proficiency

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Experience

    • Brazil
    • Textile Manufacturing
    • 500 - 600 Employee
    • Process & Improvement Manager
      • Nov 2021 - Present

    • Process Improvement and Project Manager
      • Jan 2021 - Oct 2021

    • Process Improvement Engineer
      • Jul 2015 - Jan 2021

    • Operations development Specialist
      • Apr 2013 - Jun 2015

    • Consultant - Quality & regolatory affairs Specialist
      • Feb 2011 - Mar 2013

      Consulting and design of quality management system (ISO 9001 and ISO 13485).Consulting to Medical Devices Companies on Regulatory Affairs, especially on:- Data entry related to Medical Device in the Medical Device Data Bank of Italian Ministry of Health;- Management of relations with the Ministry of Health;- Monitoring of compliance with current regulations for waste disposal (electrical and electronic equipment, batteries and accumulators, etc.);- Revisions of standards and laws related to Medical Devices;- Classification of Medical Devices in accordance with Directive 93/42/EEC, and its amendments.Consulting and support in the CE marking Medical Devices in accordance with Directive DM 93/42/EC and its amendments.Clinical engineering consulting especially the participation in the drafting of global service projects for biomedical technology management of public and private hospitals.

    • Italy
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Consultant – Quality & CE marking
      • Oct 2010 - Nov 2010

      Consulting on quality management system and EC certification- Editing, organization and revision of the documentation concerning the quality control system and the EC marking of Orthodontic Medical Devices. Consulting on quality management system and EC certification- Editing, organization and revision of the documentation concerning the quality control system and the EC marking of Orthodontic Medical Devices.

    • Consultant – Quality & CE marking
      • Jun 2010 - Jul 2010

      Consulting on quality management system and EC certification of medical devices in accordance with Directive 93/42/EEC amended by Directive 2007/47/EEC.- Revision of technical files on medical device implants (orthodontic surgery). Consulting on quality management system and EC certification of medical devices in accordance with Directive 93/42/EEC amended by Directive 2007/47/EEC.- Revision of technical files on medical device implants (orthodontic surgery).

    • Gait Analysis Assistant - Trainee
      • Oct 2006 - Dec 2006

      Assistance during tests of gait analysis, use of protocols (SAFLO, DAVIS), assistance during electromyography test. Assistance during tests of gait analysis, use of protocols (SAFLO, DAVIS), assistance during electromyography test.

Education

  • Politecnico di Milano
    Undergraduate final examination Industrial engineering
    2010 - 2010
  • Politecnico di Milano
    Master of Science Degree in Biomedical Engineering, Bioengineering and Biomedical Engineering
    2007 - 2010
  • Politecnico di Milano
    Bachelor of Science Degree in Biomedical Engineering, Bioengineering and Biomedical Engineering
    2004 - 2007
  • M.G. Agnesi - Merate (LC)
    Secondary school-leaving certificate
    1999 - 2004

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