Danielle Cook
Quality Assurance / Regulatory Affairs Specialist at Wave Neuroscience- Claim this Profile
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English Native or bilingual proficiency
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French Limited working proficiency
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Bio
Experience
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Wave Neuroscience
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United States
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Wellness and Fitness Services
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1 - 100 Employee
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Quality Assurance / Regulatory Affairs Specialist
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Apr 2022 - Present
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Applied Medical
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Drafting Team Lead
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Jun 2016 - Apr 2022
I was responsible for the training and managing of five drafters in order to maintain the uniformity of document control practices within the department.Tasks include*Managing and training five people.*Introducing new technology and systems to my team.*Communicating with my team and other groups in the company to make sure projects aregetting completed.*Making sure the department complies with both company and FDA document controlstandards.*Organizing projects
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Associate Drafter
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Sep 2011 - Apr 2022
Created a system within an engineering department in order to create, regulate, and distribute drawings from CAD models in order to process them within an existing document control system. Tasks included: *Using SolidWorks to create drawings for mechanical parts.* Working as the department's internal document control to produce and organize documentsfor approval.* Working on department-wide documents such as department standards, instructions, andguides.*Introducing the department to document changes and training them on new systems
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Automation Engineering Intern
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Jun 2011 - Aug 2011
Learned machining, solidworks, wiring, and other engineering techniques. Gained skills unique to the automation field and used this experience to obtain a full time job in a field I was otherwise inexperienced in.
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Applied Medical
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Regulatory Affairs Intern
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Jun 2010 - Aug 2010
Assisted to develop and maintain an organizational database for the department. Assisted to develop and maintain an organizational database for the department.
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Applied Medical
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Document Control Intern
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Jun 2009 - Aug 2009
Assisted in the upkeep of an organizational database for the company. Developed organization and database maintenance skills. Assisted in the upkeep of an organizational database for the company. Developed organization and database maintenance skills.
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Applied Medical
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Field Operations Intern
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Jun 2008 - Sep 2008
Used SAP to create easily accessible links to documents within the system in lieu of typical network storage. Used SAP to create easily accessible links to documents within the system in lieu of typical network storage.
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Education
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California State University-Long Beach
MA, History -
California State University
B.A, History; Modern Europe, World History -
Fountain Valley High School
High School Diploma, None