Barbara Baldi
Quality Engineer at Cell Marque, a Part of MilliporeSigma- Claim this Profile
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German Native or bilingual proficiency
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English Full professional proficiency
Topline Score
Bio
Credentials
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Diversity and Inclusion in the workplace
CourseraDec, 2021- Nov, 2024 -
Inclusive Leadership: The Power of Workplace Diversity
CourseraDec, 2021- Nov, 2024
Experience
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Cell Marque, a Part of MilliporeSigma
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United States
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Biotechnology Research
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1 - 100 Employee
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Quality Engineer
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May 2023 - Present
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German Language School Sacramento
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Sacramento, California, United States
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German Teacher
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Mar 2022 - May 2023
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LivaNova
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United Kingdom
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Medical Equipment Manufacturing
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700 & Above Employee
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VNS OR Support Specialist
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Oct 2017 - Sep 2019
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Validation Engineer
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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
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Engineering Intern
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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
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Group practice Dr. Fichna & Colleagues
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Ansbach, Germany
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Dental/Oral Surgical Assistant, Dental Hygienist
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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
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Education
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Ansbach University of Applied Sciences
Bachelor of Engineering (B.Eng.), Biomedical/Medical Engineering -
Ansbach University of Applied Sciences
Bachelor of Engineering (B.E.), Biomedical Engineering