Justin Wong

Experience

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  UC San Diego

  Sept 2010 - Dec 2012

  Held lectures for 24 students and introduced them to AutoCAD, Inventor, and industry standard toolsCounseled, provided professional advice to students and stimulated their creativities when they were building their robots for our robot contest utilizing AutoCADAssisted designing the robot contest, and monitored the design studio during my office hour Performed research with Mechanical Engineering professor on the interaction of solar irradiance with engineering systems to conduct solar resource assessment and forecasting for California.Recorded and interpret irradiation and the optical depth of the sunlight with shadowband instrumentsProgrammed in MATLAB to analyze the data, which will further be used in building solar plants

  • Teaching Assistant

    Mar 2011 - Dec 2012

  • Research Assistant

    Sept 2010 - Mar 2011
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  CareFusion

  Aug 2011 - Apr 2013

  Software Quality Engineer

  Execute and manage test cases on Medical Devices utilizing automation under a regulated environment and SAP documentation.Apply knowledge of software quality engineering concepts, practices, and procedures to find software bugs in several international projects with multiple languages and write informative descriptions on these software issuesResponsible for testing and managing specific features of software product while providing feedback on functional specifications.

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  Solar Turbines

  Apr 2013 - Mar 2015

  Quality Lead

  Reviewed shop floor discrepancies and created an In Process Validation Checklist to improve the works of Package Design Engineers utilizing 6 sigma process tools and techniques.Interpreted and reviewed Mechanical Drawings to ensure drawings’ good quality for external and internal customers.Utilized quality tools, cause mapping, root cause analysis to implemented different solutions in reducing material shortages or mismatches in the Shop Floor by 50%.Performed product lifecycle management by integrating and verifying engineering changes in WindchillDesign various software excel tools to process manufacture engineering data and improve the quality of design engineer. Show less

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  Guardian Industries Corp.

  Apr 2015 - Mar 2016

  Quality Engineer

  Performed internal audit in all department to ensure the company is in compliance with ISO 9001: 2008.Conducted CAPA and root cause analysis on non-conforming products and reduced customers’ credit by 20%.Created a calibration system and procedure to ensure the measuring equipment is certified to a NIST standard.Developed procurement procedure to evaluate suppliers effectively in a timely manner. Deployed and created multiple statistical analysis tool in the manufacture process to unfold hidden discrepancies. Reviewed suppliers’ product quality and performed supplier audit to ensure quality of material. Show less

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  BD

  Mar 2016 - Apr 2018

  New Product Quality Engineer

  Participate in clinical trial study and ensure the study is in compliance to CLSI Guidelines.Lead and implement cybersecurity controls in the operating system and software application to be in compliance with FDA standards.Develop and perform computer system validation to FDA standard. Perform IQ, OQ and PQ on multiple software tools such as Team Foundation Server and TrackwiseSupport new product development to ensure work follows 21CFR820.30 design control.Assist in implementing Agile Methodology in software development process and ensure software application is developed to IEC62304 standard.Imbed risk analysis and perform FMEA in various development processes during new product development.Collaborate with multiple functional area for US IVD 510k and EU tech files submission for new reagent and software products.Support internal and external audit such as FDA, BSI and WHO. Show less

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  Lucira Health, Inc

  Jul 2018 - May 2019

  Senior Quality Engineer

  Assisted in building a quality system from the ground up for a startup company.Develop master validation plan, validation SOP, validation template for software and manufacture.Coordinate with regulatory on human factor study and develop flex study plan and risk analysis utilizing IEC 61010, ISO 14971.Manage the design history file by initiating design review, coordinating design change control, and reviewing design input documents to different applicable standards. Conduct FMEA on different subsystems and implement risk control into design. Show less

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  Align Technology

  May 2019 - now

  Senior Quality Engineer