Barbara Baldi

Quality Engineer at Cell Marque, a Part of MilliporeSigma
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Contact Information
us****@****om
(386) 825-5501
Location
Roseville, California, United States, US
Languages
  • German Native or bilingual proficiency
  • English Full professional proficiency

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Credentials

  • Diversity and Inclusion in the workplace
    Coursera
    Dec, 2021
    - Nov, 2024
  • Inclusive Leadership: The Power of Workplace Diversity
    Coursera
    Dec, 2021
    - Nov, 2024

Experience

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Quality Engineer
      • May 2023 - Present

  • German Language School Sacramento
    • Sacramento, California, United States
    • German Teacher
      • Mar 2022 - May 2023

    • United Kingdom
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • VNS OR Support Specialist
      • Oct 2017 - Sep 2019

    • Validation Engineer
      • Jan 2015 - Apr 2017

      * Responsible for managing a summative usability study for a medical device (transcutaneous vagus nerve stimulator)* Set up use cases and test scenarios as well as workflows for validation testing* Support of a 510(k) submission with the FDA * Was responsible for formative handling studies for a medical device (transcutaneous vagus nerve stimulator) in accordance with IEC 62366 - The formative studies included testing the materials used for the device, the device´s haptical properties, its design and functionality, as well as its user interface - The outcomes of these studies had impact on the device´s risk management, design, packaging, and labelling* Collect, organize, synthesize, and analyze data; summarize findings; develop conclusions and recommendations for product improvement and marketability* Technical documentation in precise compliance with 21 CFR Part 820 and European Notified Bodies (e. g. Design History File, Design Validatin Plan, Usability Engineering File) Show less

    • Engineering Intern
      • Aug 2014 - Jan 2015

      * Experienced insight into the departments of Research and Development, Manufacturing and Marketing, Risk Assessment, and Quality Management* Technical documentation in compliance with 21 CFR Part 820

    • Dental/Oral Surgical Assistant, Dental Hygienist
      • 2001 - 2009

      * Delegated tasks and managed a team of assistants, including employee scheduling * Trained new personnel and apprentices * Assisted in dental and oral surgical procedures: - Preserving and sustaining care - Prosthetic care - Surgical care such as surgical removals of teeth, root amputations, insertion of implants * Performed professional oral cleaning * Interacted with patients in and out of the operating room * Responsible for meeting hygienic and sanitary standards such as disinfecting and cleaning dental and surgical devices and accessories * Managed appointments * Experience with working in sterile environment *Managed material and devices purchasing Show less

Education

  • Ansbach University of Applied Sciences
    Bachelor of Engineering (B.Eng.), Biomedical/Medical Engineering
    2011 - 2015
  • Ansbach University of Applied Sciences
    Bachelor of Engineering (B.E.), Biomedical Engineering
    2011 - 2015

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