Primary Tasks and Responsibilities：
1）Responsible for building, growing and leading the Engineering team.
2）Be the driver for pulling over the technical processes from Germany.
3）Responsible for process validations together with the quality department as well as maintaining the high availability of the necessary equipment of the entire Shanghai site.
4）Important player in setting up the plant and being able to match the timelines to get the facility approved.
Skills / Competencies：
1）Minimum 5 years experience in an ISO 13485/GMP environment
2）Minimum 2 years supervisory/management experience
3）Demonstrated experience with regulations in the medical device and/or pharmaceutical industries
4）Detailed knowledge and experiences in ISO 13485, ISO 14971, QSR (FDA), GMP (CFDA)
5）Special skills in product and process qualifications, verifications and validations
6）Bachelor’s or Master’s degree in a scientific field (Engineer Medical Devices, Technical, Chemical or equivalent with masters degree preferred with a focus on / special skills in process qualification and validation.
7）Must have the ownership of all processes and split that knowledge over the department.
8）English (fluent in speaking and writing)
Chinese (fluent in speaking and writing)
German (any knowledge is helpful)