MAIN JOB DUTIES/RESPONSIBILITIES：

This individual is responsible for coordinating cross-function projects in cross-border markets, ensuring that all daily operations/project related initiatives are smooth delivered & well-aligned.

l Ensure suppliers are clear on all Company and International standards, processes and procedures as they relate to various medical devices.

l Perform in line and finished product verification in accordance with Company and International Standard to ensure acceptable -quality.

l Work with other functional team (QA and Souring) to determine appropriate testing parameters for the products to ensure limited failures in product.

l Perform QMS audit to identify opportunities for continuous improvement on process control, production control and quality control.

l Undertake general and basic social compliance assessments to evaluate supplier CSR performance.

l Work with Suppliers to help resolve various customer complaints. Specifically, help with root cause investigations and analysis. Implement CAPAs based on root cause investigations to reduce complaint numbers. Ensure that solutions to quality issues are properly implemented and upheld.

l Gathering and make inspection plan with QC team. Work with suppliers and Company QC team in South East Asia to reduce product rejections.

REQUIREMENTS & QUALIFICATIONS:

l Junior college degree above in Mechanical Engineering, or Material, or Industrial engineer or Medical device related engineering field required.

l 3+ years of engineer experience, project management is preferred.

l Understanding of quality system requirements (ISO 13485 or ISO 9001)

l Ability to read and interpret product specifications and drawings

l Strong capability to multi-task in a dynamic environment.

l Proactive, Detailed & Result-oriented, Self-motivated.

l Exceptional organizational skills and the ability to balance your attention to detail with swift execution - we need to do things quickly and seamlessly.

l Team player, works with others proactively, efficiently, and effectively.

l Excellent capability in MS office (word, excel, power-point) and e-tools.