Coordinate multi-functional team (BU/R&D/Sourcing/Supply Chain/Manufacturing) for key NPI and ECR/ECO milestones ensure effective communication and efficient outcome.

Responsibilities:
- Make quality planning for change phase, ensure quality requirements are identified and implemented. Finish the quality task in the project output list. Participate in PFMEA and control plan compilation. Support the problem solving for project and change phase
Manage supplier deliverables on NPI and ECR/ECO, with support from sourcing/engineering/supplier quality functions.
- Expert in verification and process validation. Manages contractor manufacturers and suppliers when working on manufacturing process/equipment installations, modifications, and upgrades.
- SME of Sterilization. Manages contractor manufacturers and suppliers for sterilization process validation. Provide quality reviews of plans, procedures, and reports for validation activities.
- Work with suppliers on the complaint investigation.
- Support product registration and audit from NPI, change control perspective.

Qualifications:
- Bachelor or above in engineering or scientific discipline
- Fluent English speaking and writing as working language
- A minimum of 5 years of experience with quality assurance or design control, preferably in the medical devices industry.
- ISO13485/EU MDR/FDA 21 CFR 820
- Understand different cultures and can work with different regional team member