Quality Engineer

* Activities and relevant KPI Targets:- 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.* 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.

* Qualification:- 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

- Lương hấp dẫn, tăng ca, THU NHẬP TỪ 8.000.000 – 15.000.000 VNĐ- Phụ cấp: đi lại, nhà ở, tay nghề; xe nâng (nếu có chứng chỉ xe nâng)- Tham gia đầy đủ BHXH, BHYT, BHTN theo quy định. Bảo hiểm TNCN 24/24, bảo hiểm sức khỏe tư nhân và gói khám sức khỏe hàng năm với chi phí cao- Được cấp phát đồng phục, bảo hộ lao động- Môi trường làm việc máy lạnh, an toàn, sạch sẽ, năng động- Thưởng hàng năm, tiệc cuối năm, tiệc teambuilding hàng quý- Lì xì đầu năm, quà vào các dịp lễ, tết- Tiệc cuối năm, tiệc teambuilding hàng quý, du lịch công ty

Cập nhật gần nhất lúc: 2025-10-21 11:25:03