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:
- Expert of Sterilization. Manages contract manufacturers and suppliers for sterilization process validation.
- Provide quality reviews of protocols, procedures, and reports for validation activities.
- Sterilization supplier management, including qualification, audit, routine process control and annual process stability review.
- Support audit from Notified body and customers regarding sterilization, sterility test, bioburden and endotoxic test.
- Finish the quality task in the project output list. Participate in PFMEA and control plan compilation. Support the problem solving for project and engineering change phase.
- Manage supplier deliverables on NPI and ECR/ECO, with support from sourcing/engineering/supplier quality functions.
- Expert in process validation. Manages contractor manufacturers and suppliers when working on manufacturing process/equipment IQ/OQ/PQ, modifications, and upgrades.


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