Quality Engineer

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

1. 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