# Quality Engineer > Nextern · Bến Cát, Vietnam · — · Posted 2025-09-24 **Workplace:** on_site ## 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 ## Apply [Apply at Nextern](https://apply.workable.com/nextern/j/31508171B7/apply) --- Powered by [Workable](https://www.workable.com)