Steven Huang

Quality Assurance Associate at Nature's Care Manufacture Pty Limited
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Contact Information
us****@****om
(386) 825-5501
Location
Carlingford, New South Wales, Australia, AU
Languages
  • English -
  • Chinese -

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5.0

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Yashar Sadiq

Steven is a dedicated hard working individual who was the Quality Engineer at CathRx Ltd. a start-up medical device company. He was responsible of raising non-conformance and closing out of quality related issues and working with production staff on day to day basis.

Samar Omari

Steven is a hard working individual who was the quality representative responsible for product release, raising non-conformances and closing out of quality related issues. He will definitely add value in all his future endeavours.

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Credentials

  • CRISC Cert Prep: 2 IT Risk Assessment
    LinkedIn
    Sep, 2022
    - Nov, 2024
  • Excel 2019 Essential Training
    LinkedIn
    May, 2020
    - Nov, 2024
  • Excel: Implementing Balanced Scorecards with KPIs
    LinkedIn
    May, 2020
    - Nov, 2024
  • Lean Six Sigma Foundations
    LinkedIn
    May, 2020
    - Nov, 2024
  • Managing Logistics
    LinkedIn
    May, 2020
    - Nov, 2024
  • Managing and Analyzing Data in Excel (Office 365/Excel 2019)
    LinkedIn
    May, 2020
    - Nov, 2024
  • Operational Excellence Foundations
    LinkedIn
    May, 2020
    - Nov, 2024
  • Project Management Foundations: Communication
    LinkedIn
    May, 2020
    - Nov, 2024
  • Quality Management Foundations
    LinkedIn
    May, 2020
    - Nov, 2024
  • The Data Science of Experimental Design
    LinkedIn
    May, 2020
    - Nov, 2024
  • Being an Effective Team Member
    LinkedIn
    Jan, 2019
    - Nov, 2024
  • QMS Leader Auditor
    SAI Global Assurance
    Jan, 2019
    - Nov, 2024
  • PMP
    -
    Oct, 2012
    - Nov, 2024

Experience

    • Australia
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Associate
      • Jun 2020 - Present

      QMS documentation, Product / Process validation, Induction and job related quality training, Change control, Complaint and CAPA, Quality review QMS documentation, Product / Process validation, Induction and job related quality training, Change control, Complaint and CAPA, Quality review

    • Australia
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • QA Officer
      • May 2018 - Jun 2020

      QMS documentation, Internal audit, Monthly quality data trending and reporting, CAPA & Complaints, Supplier management, Coordinate with Design review. QMS documentation, Internal audit, Monthly quality data trending and reporting, CAPA & Complaints, Supplier management, Coordinate with Design review.

    • Australia
    • Hospitals and Health Care
    • 1 - 100 Employee
    • QA/RA Officer
      • Jan 2013 - May 2018

      Develop and maintain company QMS documentations and operation compliance. Manage component suppliers, internal audit, batch release, sterilisation validation and stability testing. Handle customer complaint, non-conforming investigations and manage CAPA action plan. Production KPI, inspection quality plan and technical reports for management review and post market surveillance. Develop and maintain company QMS documentations and operation compliance. Manage component suppliers, internal audit, batch release, sterilisation validation and stability testing. Handle customer complaint, non-conforming investigations and manage CAPA action plan. Production KPI, inspection quality plan and technical reports for management review and post market surveillance.

    • Ireland
    • Food and Beverage Services
    • 700 & Above Employee
    • Ingredient and flavor R&D
      • Aug 2012 - Dec 2012

      Testing on new designed food complex products Testing on new designed food complex products

    • New Zealand
    • Appliances, Electrical, and Electronics Manufacturing
    • 100 - 200 Employee
    • Overseas QA Representative
      • Dec 2011 - Apr 2012

      Product Development and China SKOPE Quality Departmental Management, QMS documentation and compliance, New Product Verification, Customer complaint and resolution management Product Development and China SKOPE Quality Departmental Management, QMS documentation and compliance, New Product Verification, Customer complaint and resolution management

    • United States
    • Biotechnology Research
    • QA Consultant
      • Apr 2011 - Oct 2011

      QMS gap analysis, QMS compliance, CAPA and Quality improvement QMS gap analysis, QMS compliance, CAPA and Quality improvement

    • Australia
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • QA Officer
      • Mar 2010 - Feb 2011

      Batch release and QPS documentation, complaint managment and CAPA implementation Batch release and QPS documentation, complaint managment and CAPA implementation

    • Australia
    • Medical Device
    • 1 - 100 Employee
    • Quality Control Engineer
      • Sep 2008 - Mar 2010

      -Work in the high regulated class III medical device company as Quality Engineer -Support Quality manager on NPI document review and delivery -Quality check from inventory to finished goods and QA release using ERP system -Nonconforming report and data log management -Assist NPI production pipeline validation and facility calibration -Archive batch documents and related outsourcing analysis report -Monitoring and reporting the effectiveness of the corrective and preventive action processes and tools. Measure the effectiveness of the CAPA. -Assist plan and implement on-going improvements to the quality management system -Support and implement internal audit activities as schedule Show less

    • Australia
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • QA/QC Officer
      • May 2007 - Sep 2008

      -Evaluate supplier goods quality, clean room surgical customer pack quality check and QA release -Control documents and sample library, validate high volume manufacture process and facilities -Control warehouse movement and BOM using ERP system -Review SOP files, control change and conduct internal audit -Evaluate reject goods and investigate non-conforming raw material and goods -Evaluate supplier goods quality, clean room surgical customer pack quality check and QA release -Control documents and sample library, validate high volume manufacture process and facilities -Control warehouse movement and BOM using ERP system -Review SOP files, control change and conduct internal audit -Evaluate reject goods and investigate non-conforming raw material and goods

    • Chemical Engineering Specialist
      • 1997 - 1999

      Lab research chemist Lab research chemist

    • Senior Chemical Engineer
      • 1996 - 1999

      R&D on catalysts and NPI process for chemical/oil/fertilizer plants R&D on catalysts and NPI process for chemical/oil/fertilizer plants

Education

  • University of New South Wales
    Postgraduate by research, Chemical Engineering & Industrial Chemistry
    2000 - 2004
  • Tianjin University
    Bachelor, Engineering
    1986 - 1990

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