Sara Nakamura's Professional Skills Radar Chart
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Sara Nakamura's Estimated Salary Range
Frequently Asked Questions about Sara Nakamura
What company does Sara Nakamura work for?
Sara Nakamura works for 23andMe
What is Sara Nakamura's role at 23andMe?
Sara Nakamura is Sr. Quality Engineer, Document Control & Training
Sara Nakamura's phone (213) ***-*372
What industry does Sara Nakamura work in?
Sara Nakamura works in the Medical Devices industry.
About Sara Nakamura
💼 Past Experience
Sara Nakamura's Education:Sara Nakamura holds a B.S. in physics from MIT in 2003. She then earned an M.S. in engineering from Stanford University in 2006. Nakamura then completed her doctorate in engineering from University of Utah in 2016.
Sara Nakamura has a BS in Cellular and Molecular Biology from San Francisco State University in 2005. After attending SF State, she trained as a research scientist at San Diego Veterans Affairs Medical Center where she was a research associate at the Molecular Genetics Lab. Following three years of research and cross-training at two other labs, she completed her PhD in Veterinary Molecular Genetics at the University of California, Davis in 2013. Sara's research focuses on the study of animal genomic materials and has involved her thesis advisor in significant grants and awards.
💡 Technical & Interpersonal Skills
Sara Nakamura is currently a Facilities Asset Coordinator at ALZA Corporation from June 2007 to August 2007 (3 months) in Mountain View, CA. Participate of the Leadership Development Program (Internship). QA Document Control & Training Lead at 23andMeSr. QA Specialist & Complaint Management at miraDry, Inc. from October 2017 to January 2020 (2 years 4 months) in Santa Clara, California. Manage complaint handling and reporting process by determining reportability of product and patient complaints, preparing and submitting eMDRs and/or Vigilance Reports, draft responding to follow-up inquiries from regulatory agencies/distributors, monitoring incidence rates, conducting monthly patient-related complaints meetings, and performing analysis for patient complaints.Manage quality and safety training program by developing training materials (e.g. competency training program), conducting new hire, sales, and refresher training, and maintaining training databaseMaintain information in compliance databases to produce quality trend reports for monthly reports and management reviewsManage and conduct internal audits to ensure compliance with regulatory requirements (e.g. MDSAP)Assist or lead external quality audits (i.e. FDA, Notified Body, and suppliers)Manage Corrective and Preventive Action (CAPA) process by initiating CAPAs, developing a corrective or preventive action plan, performing effectiveness verification, and monitoring open CAPAsManage document control activities (paper & electronic systems) including review processing, tracking, and maintaining all quality management system Change Order (CO) and controlled documents through origin, review, approval, distribution, revision, storage, archive, retrieval, and obsolescence Develop and maintain the safety programs, policies/permits, conduct safety inspections, escort county/city safety inspectors or insurance brokers, monitor hazardous materials, and manage medical/chemical waste disposal activitiesMaintain information in compliance databases to produce quality trend reports (e.g. document control and training metrics, and internal audit observations) Conduct safety inspections, including evaluation of fire extinguishers, eye washes, and lab areas, identifying and implementing corrective and preventive actions as requiredMonitor hazardous material handling and storage, janitorial, and pest control service activitiesPerform incident analysis and ensure corrective actions are taken for any environmental, health, or safety hazardsManage medical waste and hazardous waste disposals activitiesObtain and maintain the required environmental permits and licenses as well as prepare and submit the required environmental applications, reports and letters to Government AgenciesComplete annual reports related to hazardous waste generation.
In a nutshell
Ranked #1,353 out of 27,060 for Sr. Quality Engineer, Document Control & Training in California
Introversion (I), Sensing (S), Thinking (T), Perceiving (P)
2 year(s), 0 month(s)
There's 92% chance that Sara Nakamura is seeking for new opportunities
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