Quality Assurance
Resume:
Erika Andrade
Chandler, Az **225
adeybw@r.postjobfree.com
PROFESSIONAL EXPERIENCE
BECTON DICKINSON Tempe, AZ
Quality Assurance Specialist November 2018 – Present
Responsible for managing Medical Device Reporting, Complaint Handling/Resolution, and FDA Compliance.
Communicated with health professionals and sales representatives to record medical device deficiencies.
Responsible for analyzing complaint records to report qualifying device malfunctions and adverse events to the FDA for post-market surveillance.
Proficiently managed tracking, evaluation, and submission of Medical Device Reporting process to improve timeliness submission.
Analyzed engineer investigation reports with quality methodologies referencing corrective action policies and documents (PFMEA, DFMEA, AQLs, CAPAs).
Participated in the Voluntary Malfunction Summary Reporting team; responsible for writing, reviewing, and submitting quarterly reports for eligible medical device malfunctions to the FDA.
OSCAR HEALTH Tempe, AZ
Care Enrollment Representative October 2017 – February 2018
Interviewed potential and current clients to determine appropriate healthcare coverage and pricing.
Responsible for explaining the Health Insurance Marketplace application process and requirements.
Facilitated computer-based application and enrollment process completion into internal health plans and Health Insurance Marketplace plans.
Educated members on different medical plans, explanation of benefits/copays, and health network.
Managed membership updates and mitigated complex problems between clients and healthcare providers.
PAR PLUMBING Chandler, AZ
Administrative Assistant March 2013 – April 2015
Managed calendar activities, service logistics, and employee schedules.
Documented service work orders utilizing an electronic database.
Maintained a filing system and supported accounting data entry as needed.
Supported phone lines and email correspondence to ensure timely service dispatch.
Communicated with clients and technicians to coordinate service appointments.
MACY’S CREDIT Tempe, AZ
Fraud Prevention Specialist October 2011 – November 2012
Initiated customer/victim fraudulent cases and actively monitored account activity to reduce future incidents.
Solved complex problems by gathering data findings and communicating with involved parties and departments.
Responsible for researching, analyzing, and identifying fraud activity and fraud trends.
Escalated trends of suspicious activity and reported to upper management.
Communicated with clients to verify account activity was intentionally processed.
EDUCATION
ARIZONA STATE UNIVERSITY Mesa, AZ
M.S. Human Systems Engineering, May 2021
ARIZONA STATE UNIVERSITY Tempe, AZ
B.S. Psychology, B.S. Criminology & Criminal Justice, August 2018
CHANDLER-GILBERT COMMUNITY COLLEGE Chandler, AZ
A.A. General Studies, December 2014
ADDITIONAL SKILLS
Microsoft Office
R/RStudio
SPSS
Minitab
Axure RP
JIRA
TrackWise
Confluence
SharePoint
Bilingual (English/Spanish)
JD Edwards EnterpriseOne
MasterControl
CERTIFICATIONS
Six Sigma Green Belt
Ira A. Fulton Schools of Engineering, Arizona State University
Date of completion: December 2020
Lean Six Sigma Yellow Belt
Ira A. Fulton Schools of Engineering, Arizona State University
Date of completion: June 2020
The argument is that humans construct internal representations in order to explain their experiences
The argument is that humans construct internal representations in order to explain their experiences
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