Post Market Quality Engineer
Resume:
Karen Nguyen
***** **** ******, *******, ** *****
Email: *********@*****.***
OBJECTIVE
Looking for a position which integrates my knowledge and experience, and that enables me to make a positive contribution to the company.
SUMMARY OF QUALIFICATIONS
Proficient with Microsoft Office (e.g., Word, Excel, and Power Point), SAP, Agile, Sharepoint.
Working with complaint processing system: CTS, GCH.
Experience with Good Document Practices and GMP.
Capable of working independently and / or with other team members.
Excellent organization skill and record keeping
Excellent analytical and problem-solving skills.
EDUCATION
Bachelor of Science (B.S) in Food Science University of California, Davis Apr 2011
EXPERIENCES
Medtronic
Post Market Quality Engineer (07/2015 – Present)
Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
Responsible for investigating complaints to resolve both product/procedure issues determined through failure analysis, focusing on root cause analysis
Determines reportability (MDR/MDV) of complaints to FDA and other international regulatory agencies.
Interfaces with customer service and technical service and other department daily to drive timely completion of complaints
Assist in reviewing trending data to assure trend accuracy in electronic database.
Review labeling and 510(k) submissions to meet the FDA regulatory requirements.
Ensure all records are accurate and compliant FDA requirements according to 21 CFR 803 Medical Device Reporting.
Smithfield
QA Specialist (05/2013 to 02/2015)
Manage the change control system: Review, route, and release change orders.
Monitoring status of in-process document changes and coordinate the workflow to ensure timely revisions.
Validate QC records to ensure follow-up actions is completed include investigation, correction action and preventive action.
Organize and assist in system software/Quality training and other training as required
Follow-up action items identified through the audit process. Monitors follow-up steps through to project completion.
Support Quality in both external and internal audits.
Maintain database for all documents received as hard copy and EDMS.
Review and update GMP, SOPs.
Organize and manage documents on file and electronic database to ensure compliance with FDA, State and local regulation.
Monsanto
Quality Assurance (09/2012 – 06/2013)
Perform routine testing samples, prepare dilution sample for analysis, standard reagent solution such as buffers, mobile phase
Collects and analyze data to establish testing method on raw ingredients and finished products
Verify and compare results against control/standard
Perform product quality control to analyze pH, titration, moisture, viscosity, color, spectrum analysis, brix, salt level, water activity)
Chemistry Laboratory, University of California, Davis
Laboratory Assistant 09/2009 – 05/2011
Prepare sterile microbiological media, reagents, buffers, and other solutions according to specific formulas and protocols.
Properly handle micro-pipet and prepare reagent by dilution
Perform routine lab safety and sanitary work areas
Microbiology, University of California, Davis
Research Undergraduate 2010
Study specific areas in cafeteria campus by swabbing method to target E.Coli, Coliform, Listeria and Aerobic bacteria under Dr. Young, Chemisty professor.
Gain hand-on experience of taking sample and good laboratory technique.
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