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Quality Engineer
Quality EngineerNextern • Bến Cát, Binh Duong, VN
Quality Engineer

Quality Engineer

Nextern • Bến Cát, Binh Duong, VN
30+ days ago
Job type
  • Quick Apply
Job description

Activities and relevant KPI Targets :

1. The following processes are key to QE performance within Nextern and between Nextern and our key customer collaborators. This role must be proficient at achieving outcomes on-time, with high quality documentation content, and cross-functional team awareness / support (internal & external) :

  • Create required documentation that relevant to product specifications and requirements (Process flow, control plan, inspection criteria…)
  • Manage inspection report follow AQL for each shipment and / or production lot.  Review device history record and approve the product disposition
  • Process Qualification & Validation
  • Equipment (Functional Test, Assembly Fixtures, Manufacturing Aids, etc…) Selection & Qualification
  • Process Control & Yield / Trend Monitoring
  • Customer complaint support regarding the Failure Analysis of Returned Products (Out of Box & Fielded), Return Material Authorization (Customers to Nextern), Return Material Authorization (Intra Nextern) Servicing & Refurbishment of Fielded Products
  • Non-Conforming Material Processing (Manufacturing, Supplier, & Engineering Change Causes)
  • Audit, CAPA & SCAR Processes support
  • Other responsibilities assigned by the superior

2. The following processes are key to QE performance follow the superior appointment

Incoming control activities, including but not limited to :

  • Prepare Incoming Inspection Criteria. Ensure that all related inspection and testing activities with regard to the established standards
  • Control inspection materials in both ERP system and physical
  • Maintain record of inspection, testing, equipment calibration, maintenance, etc. per procedures. Scan & archive records in the control system
  • Process control activities, including but not limited to :

  • Perform the Equip / Process Qualifications. Control of Equipment Calibration & Preventive Maintenance
  • Follow up in-process control activities, review DHR and perform product disposition
  • Supplier Quality management activities, including but not limited to

  • Initialize PPAP (Production Part Approval Process) to supplier, gather and maintain all required documentation
  • Maintains PPAP master samples
  • Travel to supplier locations to conduct audits and inspections
  • Improvement activities

  • Initiate timely CAPA, SCAR, Non-Conforming Material Processing and follow up
  • Material Issue Investigation Lead, NC product disposition Lead, Traceability Lead
  • Customer complaint investigation support
  • Build excellent quality reports
  • Requirements

  • Bachelor’s degree or higher of technical university (University of Technology is preferred)
  • Minimum 4 years’ experience in process quality management.  Experience in medical device is preferred
  • ISO9001 : 2015 certification is mandatory (ISO13485 certification is preferred)
  • Experience in Solving problems (follow 8D)
  • Experience in statistical and risk management (FMEA)
  • Experience in process qualification
  • Experience in excel (especially VBA), word, excel and PowerPoint
  • Language : must be highly fluent in English (written & verbal)
  • Knowledge about improving concepts (Kaizen, 6 sigma, lean manufacturing...) is preferred
  • Physical Demands and Work Environment

  • Able to work overtime and accept meeting at night several times weekly
  • Able to work under high pressure
  • Able to work in cleanroom class 8
  • Benefits

    Benefits Competitive salary

    Professional and Friendly Working Environment, chance to attend employee's training and development programs

    Premium healthcare Insurance (In Vietnam) & Business travel insurance Health, social & unemployment insurance (following Government regulation)

    Company trip, New Year party, Team building

    Occasion-based offerings : Birthday, New year, Mid-Autumn

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    Quality Engineer • Bến Cát, Binh Duong, VN

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