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
Top Skills
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
