Experienced Quality Control Professional with a demonstrated history of working in the Medical Device industry. Skilled in Data Analysis, Wet Lab Techniques, Product Testing, and Problem Solving.
Overview
3
3
years of professional experience
Work History
Design Verification/Reliability Tester
Outset Medical
San Jose, CA
03.2023 - Current
Perform design verification, reliability, and feasibility testing on complex hemodialysis systems.
Write and update test protocols as required from the Systems Engineering team.
Create traceability matrices using IBM DOORs to link system requirements and test protocols.
Update documents on Agile PLM through submission of change orders.
Maintaining stock of lab supplies and equipment calibration.
Quality Control Analyst
Cepheid
Sunnyvale, CA
02.2022 - 02.2023
Laboratory testing of medical diagnostic kits.
Follow SOPs to prepare reagents and cell samples for diagnostic assays.
Cross-departmental communication with manufacturing lines, failure investigation, and engineering departments to update testing status.
Generate Device History Records containing test results with high attention to detail and GDP.
Review documents from other analysts prior to submitting to Quality Assurance department.
Education
M.S. Computer Science -
Georgia Institute of Technology
Atlanta, GA
06.2027
A.S.T Computer Science -
Foothill College
Los Altos, CA
01.2024
B.S. Biochemistry -
University of California, Los Angeles
Los Angeles, CA
06.2019
Skills
GDP
GMP
Quality Control
In-process testing
Data Analysis
Writing/updating test protocols
IBM DOORS
Agile PLM
Timeline
Design Verification/Reliability Tester
Outset Medical
03.2023 - Current
Quality Control Analyst
Cepheid
02.2022 - 02.2023
M.S. Computer Science -
Georgia Institute of Technology
A.S.T Computer Science -
Foothill College
B.S. Biochemistry -
University of California, Los Angeles
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