Well organize approval affairs, including ordering approval Demo/Sample from CS, requiring technical/legal documents from Manufacturer, draft approval standard, completing testing with support from Service/Manufacturing site, prepare and submit approval documentation to SFDA and responding questions from SFDA in a timely manner.
Complete product registration and re-registration according to approval plan
Fetch product license
Well communication with related interface to smooth product registration
Back up whole registration file, including technical documents from manufacturer, product std, IFU(EN&CH), application form and other legal documents(EN&CH) submitted to SFDA
Prepare and maintain an index of registration documents
Ensure its security and completeness
Active cooperates with RA/DD/SE for updating local/worldwide standards.
Contact manufacturer for technical/legal documents
Answer the questions during type testing and/or SFDA technical review
Contact MKT/Sales/CS for Demo and status of registration
Regular visit key interfaces of SFDA, e.g., technical review, standard control and registration supervision department
Other interfaces within or without Dräger
Support manager for collecting data, analyzing, sum & reporting and defining actions for improvement and other tasks assigned by Manager
Regular review the government website
Check the standards applicability and inform manufacturer the applied standard
Prepare and maintain the applied standard list
Required:
Bachelor degree and above with major in Biomedical Engineering or Medical Device Testing.
Excellent written and oral English.
At least 3 months Multinational Corporation company experience. Oversea education or working background is preferred.
Job Title: Project Engineer
Responsibility:
Lead and implement regional or local projects to achieve projects objectives.
Support to identify new projects opportunities, initial to meet business objectives.
Lead process optimization projects or process studies aiming to improve internal processes, organizations and production operation systems.
Deploy Excellence within operations.
Required:
Bachelor degree and above with major in Engineering.
Excellent written and oral English.
At least 3 months Multinational Corporation company experience. Oversea education or working background is preferred.
Job Title: Purchasing Engineer
Responsibility:
Pull China sourcing
of more parts and drive AP spent increase within global purchasing organization.
Significantly drive cost reduction to contribute global sourcing.
Manage and tracking defined IPO projects through AP supplier development.
Provide china supply market expertise and scout new technology for new product develop/transfer projects.
Establish and maintain cross-functional linkage with Plants worldwide and JVs to assure effective sharing of sourcing information.
Other assignments by direct manager.
Required:
Master degree in Engineering.
Good command of MS office.
Excellent written and oral English.
At least 3 months Multinational Corporation company experience. Oversea education or working background is preferred.
Job Title: Quality Affairs Specilist
Responsibility:
Participate in the definition of quality objectives and coordination of all functions involved in Dräger Medical
Analysis and follow through the agreed and coordinated quality management objectives, transfer to Gate 5
Check the initiation of CAPA product relevant committees in the decision, if it is to achieve the quality objectives necessary to monitor the full and timely implementation and
Initiation of Ship Holds in the relevant decision bodies
Management of field operations in the definition of the processes
Development, implementation and maintenance of statistical tools and methods within the area of responsibility
Functional and disciplinary guidance of the Warranty Specialist in the management of relevant field information
Ensure that a regular, consistent, meaningful and effective reporting to the Product Quality SBF is available
Management of specific functional and cross-departmental quality improvement projects to products and processes and accordingly to meet the objectives of the project team needed more
If needed, support, responsibility, if necessary, the timely, complete and final implementation of the CAPA system relevant SBF
Support for external and internal audits and implementation of corrective measures, if necessary
Required:
Bachelor degree and above with major in Biomedical Engineering or Medical Device Testing.
Excellent written and oral English.
At least 3 months Multinational Corporation company experience. Oversea education or working background is preferred.