Quality Engineer

- Work with the sending site and local teams to collect and analyze historical quality data, defect trends, and process capability information to proactively address known risks before production launch.
- Develop and maintain process risk management documentation (PFMEA, control plans) to identify, mitigate, and monitor process risks during transfer and production ramp- up.
- Support Test method validation (TMV), process validation activities (IQ/OQ/PQ), etc with ensuring protocols, acceptance criteria, and documentation meet regulatory and QMS requirements.
- Collaborate with cross- functional teams including engineering, manufacturing, regulatory, supply chain, and suppliers to integrate quality requirements into all phases of the transfer plan, from process setup through production handover.
- Ensure quality engineering activities for NPI manufacturing transfer are compliant with quality requirement, including traceability of DOTM, process validations, etc.
- Develop, modify, apply, and maintain quality standards and protocols for transferring products and manufacturing processes, ensuring compliance with ISO 13485:2016 and the company’s Quality Management System (QMS).
- Review and manage quality issues (e.g. nonconformances) during transfer builds, ensuring timely closure, root cause analysis, and escalation into CAPA when required.
- Define and implement inspection methods, sampling plans, and quality controls for transferred processes, including in- process and final inspection stages.
- Coordinate readiness of manufacturing equipment, tooling, and inspection systems to support process qualification and production start- up.
- Participate in readiness reviews, sp builds, and verification activities to ensure process capability, product quality, and yield targets are met.
- Ensure audit readiness by maintaining complete, accurate, and compliant records for validation, inspection, and risk management activities.
- Apply Medtronic Performance System (MPS) principles and implement MPS tools to drive problem- solving, waste elimination, and continuous improvement throughout the product transfer lifecycle to enhance process stability, improve efficiency, and sustain high- quality output post- transfer.
- Promote and ensure First Time Quality at the Source (preventive/predictive approach)

- Full participation in Social Insurance, Health Insurance, and Unemployment Insurance as per government regulations.- Health Insurance for employees + spouse and children.- Paid leave to care for family members.- Annual health check- ups.
- 13th- month salary bonus & performance- based bonuses.
- Various annual activities such as company trips, sports events, holiday gifts (Lunar New Year, Mid- Autumn Festival, Christmas, birthdays, International Children&039;s Day, International Women&039;s Day, Vietnamese Women&039;s Day, etc.).

Cập nhật gần nhất lúc: 2026-03-30 12:30:03