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 standardsControl inspection materials in both ERP system and physicalMaintain record of inspection, testing, equipment calibration, maintenance, etc. per procedures. Scan & archive records in the control systemProcess control activities, including but not limited to :
Perform the Equip / Process Qualifications. Control of Equipment Calibration & Preventive MaintenanceFollow up in-process control activities, review DHR and perform product dispositionSupplier Quality management activities, including but not limited to
Initialize PPAP (Production Part Approval Process) to supplier, gather and maintain all required documentationMaintains PPAP master samplesTravel to supplier locations to conduct audits and inspectionsImprovement activities
Initiate timely CAPA, SCAR, Non-Conforming Material Processing and follow upMaterial Issue Investigation Lead, NC product disposition Lead, Traceability LeadCustomer complaint investigation supportBuild excellent quality reportsRequirements
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 preferredISO9001 : 2015 certification is mandatory (ISO13485 certification is preferred)Experience in Solving problems (follow 8D)Experience in statistical and risk management (FMEA)Experience in process qualificationExperience in excel (especially VBA), word, excel and PowerPointLanguage : must be highly fluent in English (written & verbal)Knowledge about improving concepts (Kaizen, 6 sigma, lean manufacturing...) is preferredPhysical Demands and Work Environment
Able to work overtime and accept meeting at night several times weeklyAble to work under high pressureAble to work in cleanroom class 8Benefits
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