Samantha Gonzales
Seattle,United States
Summary
Seasoned Quality Assurance Analyst with 8 years of experience in healthcare, specializing in securing top-tier product quality through expert knowledge of medical devices. Proficient in implementing innovative business strategies to pinpoint crucial defects and drive process enhancements. Acknowledged for strong leadership, strategic planning, adaptability, and outstanding interpersonal skills.
Overview
8
8
years of professional experience
Work History
Quality Assurance Analyst
Abbott
REMOTE, USA
07.2017 - Current
- Proactively investigated and documented global adverse events of Abbott devices reported by healthcare professionals, sales representatives and patients.
- Imparted secondary and final reviews on domestic and foreign regulatory reports before submission to FDA to ensure regulatory compliance.
- Generated and processed over 100,000 accurate quality control reports for Abbott products (guide wires, stents, balloon dilatation catheters, vessel closure devices).
- Demonstrated technical writing expertise by authoring 5+ documentation sets for quality assurance.
- Spearheaded the development of a robust training plan for the organizations new complaints handling system.
- Collaborated closely on quarterly UAT rounds, focusing on complaint handling efficiency and system optimization.
Quality Assurance Assistant
Abbott
TEMECULA, CA
08.2016 - 07.2017
- Ascertained 100% on-time submission of 10,000+ regulatory reports, contributing to zero late reports for the year.
- Added to quality improvements in 3 major global recall investigations for Abbott devices.
- Enhanced global reporting accuracy by developing and refining standardized documentation for two countries.
- Offered comprehensive, confidential, and administrative support for the QA Department, including interaction with global authorities and knowledge of good manufacturing practices.
- Proficient in returned goods processes and systems (SAP, RET, VIPER).
Public Health Intern
Million Kids Organization
RIVERSIDE, CA
05.2016 - 12.2016
- Researched over 200+ media news articles and legal cases on child trafficking in Southern California.
- Quantified data via an Excel spreadsheet with 7 different specifications.
- Attended in-depth analytical meetings 2x a week to examine child sex trafficking data and determine theoretical modalities to assist victims.
- Supported three in-person training and outreach seminars for Riverside County Anti-Human Trafficking Task Force (RCAHT).
- Originated early draft of Predator App Library (PAL) database for social media application use to combat and educate about child sex trafficking.
Education
Master of Public Health - Global Health
University of Southern California
Los Angeles, CA05.2016
Bachelor of Arts - Journalism & Spanish
New York University
New York, NY05.2012
Skills
- Salesforce
- MS Office Suite
- FDA regulations
- Strategic thinker
- Quality processes
- Root Cause Analysis
- Project Management
- Deductive Reasoning
- Mentoring and training
- User Acceptance Testing
- Documentation and materials
- Quality Management Systems
- Training material development
- Corrective and Preventive Action
Languages
Spanish
Native/ Bilingual
Web
www.linkedin.com/in/samantha-gonzales-b94a7463
Timeline
Quality Assurance Analyst
Abbott
07.2017 - Current
Quality Assurance Assistant
Abbott
08.2016 - 07.2017
Public Health Intern
Million Kids Organization
05.2016 - 12.2016
Master of Public Health - Global Health
University of Southern California
Bachelor of Arts - Journalism & Spanish
New York University