Quality Control Medical Device
Resume:
Amy L, Duong
********@*****.***
Objective: Looking for Processing, QA, IQC and Manufacturing Technician
** ***** ********** ** *** medical device industry. Skilled manufacturer
and processor with in depth knowledge of the demand flow technologies
(Kanban) and Metric Systems. Cross trained to process in multiple product
lines. Highly skilled a testing reagents in laboratory with biotech
instruments in a controlled environment.
Professional Experience
TriReme Medical., Pleasanton, CA Quality Control Inspector
2013
Performs routine inspection ballon catheter and incoming quality control
inspection; First Article Component; Take measurement by using Micrometer,
Caliper, Snap Gage and other instrument. Provide support manufacturing
duties.
NovaTorque Inc., Fremont, CA R&D Assembly Tech
2011- 2012
Perform routine inspection at incoming IQC; First Article Components;
Labels; Mechanical and Finish Products. Take measurements using
Micrometers, Caliper, Snap and High Gage. And other measuring instrument.
Provide support for R&D Engineer and manufacturing duties.
Abbott Vascular Inc., Santa Clara, CA R&D Assembly Tech
2009-2011
Perform stent manufacturing operation, including electropolishing and use
of ultrasonic bath for wet processes. Visually inspect stents for defects
and evaluate surface quality using optical microscope. Stent crimping onto
balloon catheter and visually inspect crimped stent. Participate in balloon
expandable stent testing, including stent expansion and inspection of
expanded stents. Knowledge of general laboratory safety procedures,
including acid work.
W.L. Gore & Associates Inc., Sunnyvale, CA Assembly Tech
2008-2009
Performed semi-complex tasks in the preparation for medical device
assembly; placed parts in specified relationship to each other Device
History Record (DHR). Worked on line where tasks vary as different mandrel
models (Iliac/Aortic/Contraleg/IPSI/Trunk winding patterns) moves along
line. Accurately recorded and completed manufacturing documentation.
Certified Rotation Inspection.
Lifescan Inc., Milpitas, CA Process Technician III
1997-2006
Performed formulation/coating. Weighing and mixing chemicals to formulate
the dip to coat membrane, and meet target specification range. Visually
inspected coated membrane for defects. Maintain 0% error by using
Kinematics, Owens, and Conquip visual tables to mark and track defects.
Set up coated membrane on slitting machine to segment into tracks. Sampled
membrane lot by cutting sections of the membrane with the production
machine to be sliced. Sliced sample cards into test strips with a semi-
manual slicing machine. Segregated strips; assigned, labeled, and bottled
to be tested. Adjusted blood hematocrit and glucose level by utilizing
pipettes to add glucose solution into test tubes, then placing it into
centrifuge to separate plasma for Yellow Spring Instrument (YSI) reading.
Assigned calibration codes to test strip lots, by using a blood glucose
analyzer to ensure blood calibration is within specifications. Reviewed
data from testing lots as part of the QA process and data entry. Matched
the batch records to the barcode lot number labels in order to package the
membrane for shipping (Flanging Process). Completed all appropriate Health,
Safety, and Environment practices to meet compliance requirements. Worked
as part of Photometric Meter Manufacturing Group. Packaged material
following a sequence of event procedures (SOE). Certified On the job
Trainer for multiple product lines. Tracked associates training records in
an internal database for legal documentation. Cross-trained individuals for
flexibility across assembly lines. Working in a clean-room manufacturing
environment and Microscope. Maintained tool calibration and removal of out
date equipment from testing floor. Interacted with Technical Support,
Engineers and Quality Assurance Groups for specific experiment involving re-
work.
Education
High school diploma.
Modesto Junior College
Skills
Procedures: Buffer, Calibration, Bio-Hazard Handling, Blood borne
Pathogen, Flanging, Linearity Check, 5's (Work Area Organization) GMP (Good
Manufacturing Process) SOE (Sequence of Events) WI (Work Instruction) ISO
(International Standard Organization) FDA (Food and Drug Administration)
MSDS (Material Safety Data Sheet)
Kanban (DFT)
Machines: Environment Control Recorder, Randomizer, Splicer, Electronic
Chemical Weight Scale, Centrifuge, Pippetles, Visual Inspection tables, PH
Probe, Coating, Slitter, Spectro Photo Meter, Bag Sealer, YSI (Yellow
Spring Instrument).
Technical: MS. Excel, PowerPoint, Word.
Amy, Duong 408-***-****
Contact this candidate