Kenneth Tsang

Quality Engineer at Electro Industries
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Contact Information
us****@****om
(386) 825-5501
Location
US
Languages
  • English Native or bilingual proficiency
  • Chinese Native or bilingual proficiency
Skills

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Bio

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Credentials

  • Lead Auditor
    Ombex Engineering & Management, Inc.
    Mar, 2015
    - Oct, 2024

Experience

  • Electro Industries
    • United States
    • Appliances, Electrical, and Electronics Manufacturing
    • 1 - 100 Employee
    • Quality Engineer
      • Jun 2016 - Present

      • Review customer complaints, RMAs, and internal non-conformances to resolve quality issues. • Develop and apply effective corrective actions with zero occurrence. • Review and provide justification on First Article and non-conformance materials with cross functional departments. • Issue and review internal/supplier corrective action report. • Develop effective corrective action through root cause analysis using 8 disciplines and 5 whys. • Review manufacturing procedures and data to discover quality risks and develop process to lower the risk. • Develop procedures to calibrate equipment. • Facilitate the ISO and UL external audit. • Update/create quality operational procedures, work instructions, and form templates. • Internal audit.

  • Genadyne Biotechnologies,INC
    • United States
    • Hospitals and Health Care
    • 1 - 100 Employee
    • QA Engineer, R&D, and Regulator Affairs
      • Apr 2014 - Jun 2016

      • New medical product development cross-functional project team acting as a leading engineer including the development of hardware, software, and execution of the regulatory strategy for both US, Canada, and EU markets. • Liaise with cross-functional team members to drive regulatory deliverables such as 510(k) submissions, product labeling, SOPs, Technical File, Design Verification, Design Validation, Process Validation and Design Dossier updates. • Review change control associated with assigned products to determine regulatory impact. • Fulfill documentation requests from International RA affiliates pertaining to assigned products. • Implement and supervise pre-manufacturing and ongoing manufacturing quality control processes. • Training new employees on GMPs and quality procedures and ongoing training for current employees. • Handle non-conforming materials. • Internal audit and facilitate external audits.

Education

  • Stony Brook University
    Master of Science (MS), Materials Engineering
    2012 - 2013
  • Stony Brook University
    Bachelor of Science (BS), Engineering Chemistry
    2008 - 2012
  • Queens College
    Chemistry
    2007 - 2008

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