Shum Yu Seto

Staff Engineer, Supplier Quality Engineering at Stryker
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Location
Kawartha Lakes, Ontario, Canada, CA

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Credentials

  • Verified International Academic Qualifications
    World Education Services
    Jul, 2021
    - Sep, 2024

Experience

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Staff Engineer, Supplier Quality Engineering
      • Aug 2022 - Present

      • Provide quality management system (QMS) auditing services as part of the Stryker Global Supply team. • Ensure supplier compliance to Stryker Purchasing Controls processes, quality management system standards in ISO 9001, ISO 13485, ISO 17025. • Initiate, manage, and track to closure all audit Observations and Findings thru the Corrective and Preventive Action (CAPA) process by using Trackwise system. • Provide quality management system (QMS) auditing services as part of the Stryker Global Supply team. • Ensure supplier compliance to Stryker Purchasing Controls processes, quality management system standards in ISO 9001, ISO 13485, ISO 17025. • Initiate, manage, and track to closure all audit Observations and Findings thru the Corrective and Preventive Action (CAPA) process by using Trackwise system.

    • Netherlands
    • Hospitals and Health Care
    • 700 & Above Employee
    • Manager, Supplier Quality Management, BG in Mother and Childcare (MCC)
      • Apr 2017 - Mar 2022

      - Working in Mother and Child Care industry for both Medical and Non-Medical products. Experience of the manufacturing process in the Baby monitor, healthy feeding product such as blender, Sterilizer, Drinking Bottle, Thermometer.- Working with R&D team, NPI and supplier in Product Development, Launch & Maintenance (PDLM Project) and product lifecycle development (Modify launched design-MLD project). To arise quality criteria/requirement for supplier from industrialization stage to MP.- Guide for suppliers on product design, Design for Manufacturing/Assembly/Test (DFMAT), component qualification, process development, DOE optimization to achieve Philips’s requirement.- Implementation of Advanced Product Quality Planning (APQP) in end product and component - Align and approve the Part Submission Warrant (PSW) deliverable such as the PFMEA, Control Plan, Part Risk assessment, Process Capability Study (Cpk) in CTQ/CTS for releasing the production.- Mange the supplier on the First Pass Yield (FPY) improvement and cost down projects (DfX) for continuous improvement. - Implement Supplier Quality Improvement Programs (SQIP) in both quality system and manufacturing domain.- FOR and Cppm Performance Analysis, conduct the process audit to make sure the supplier quality sustainable.- Problem solving such as 8D, 5 Why, Fishbone diagram, PRIDE- 5S, GRR, SPC (control chart), DoE and APQP.- Knowledge on Quality Management System (ISO9001, ISO13485, Food Contact, 21 CFR 820). Qualified as ISO 9001 and 13485 Lead auditor to conduct the Supplier Qualification Audit by using the Supplier Evaluation Assessment Tool (SEAT) - Conduct the Supplier QMS Capability assessment/ Supplier Technical Capability Assessment with different function for supplier scouting to achieve quality, cost and delivery requirement.- Manage the quality cases and driving cross teamwork force to solve the quality issue (4-Block and management review).- Knowledge on Sigma Green Belt Show less

    • Assistant Manager, Supply Quality Management, BG in Mother and Childcare (MCC)
      • Aug 2013 - Mar 2017

      - Develop the supplier quality system to meet project requirement with Supplier- Work with project teams to ensure new projects meet quality expectation and delivery on time- Drive continuous improvement for supplier quality- Monitor the FOR, CPPM performance of the supplier by weekly and monthly- Report supplier performance to management team by monthly- Work with QPL and FFB team for FCR and IPM case improvement- Deploy the APQP to relative suppliers

    • Lead Engineer - Safety, Compliance & Approbation, BG in Mother and Childcare (MCC)
      • Mar 2012 - Jul 2013

      - Build Safety & Compliance Protocol for Baby Monitor- Manage to use the tool HBSRA – Hazard Based Safety Risk Assessment for product safety- Build up the testing and compliance protocol for MnCC product with difference testing laboratory and arrange the testing issue- Manage laboratory competence in delivery baby monitor testing, including laboratory selection.- Establish and maintain ISO procedure for Safety and Compliance process.- Maintenance and update the product certificate and compliance - Study and delivery the new international safety/ regulation requirement (Safety, R&TTE, RoHS, REACH, Country requirement) - Work and guide the Vendor/ Supplier how to make the product comply with the safety testing and requirement, as the consultant for the vendor/ supplier of the safety standard with technical support.- Safety Analysis for Integral Problem Management (IPM)/ return product Show less

    • United States
    • International Trade and Development
    • 500 - 600 Employee
    • Project Engineer
      • Sep 2001 - Mar 2012

      - Working on Lab. Testing Services provider, as the Engineer Assistant (2001), Project Handler I (2003), Engineer (2005), Associate Project Engineer (2006), and Project Engineer (2010) - Mainly working on Audio-Video (AV) (e.g. Docking System, Amplifier, DVD Player and Power Supply) and ITE product (e.g. Power Supply, Speaker and Paper Shredder) for product safety investigation in UL and CB. - Project Management - Prepare the project planning, Conduct the product construction analysis, arrange the testing schedule and prepare the UL and CB Report according to client’s project schedule and both UL/CB/Client requirements. - Familiar with UL/IEC 60065 and UL/IEC 60950-1 - Knowledge on Hazard-Based Safety Engineering (HBSE) - Knowledge on UL826, UL1678, UL2442, UL1492, UL2089, UL697, UL810, UL1310, UL1411, UL1413, UL1585, and UL1977.- As the Reviewer (Level 3) on UL/IEC 60065, UL 826 and UL 1413 - Provide the External Seminar and Internal Training of Hazard-Based Safety Engineering (HBSE) - Co-operate/ communicate with client during product development stage, have the preliminary review of the product prototype and help client to solve the technical/ construction problem to let the project run smoothly during the investigation - As the Industry File Review (IFR) coordinator in UL Hong Kong. To monitor the IFR schedule and guide the Engineer to understand the IFR process. Also, work with other global office to manage the IFR schedule -As the DAP Lead Auditor in ISO 17025 to support the DAP assessment for CTDP and SMT Client in Greater China. Show less

Education

  • City University of Hong Kong
    Bachelor of Science (B.Sc.), Electrical, Electronics and Communications Engineering
  • Hong Kong Association for Testing, Inspection and Certification Limited
    Certificate of Completion in Laboratory Quality Management-ISO/IEC 17025 and Internal Audit
  • Hong Kong Technical Colleges
    Higher Diploma in Communication Engineering, Credit

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