This position is set up to take care of all operation quality related issues, such as Deviation handling, NC handling, Products inspection, goods return request approval, IFU/label review, other quality related issues in 3PL warehouse, MAH manufactuer, maintenance of NMPA tracking system, part of the QMS&PMS quality issues, such as operation related procedures, complaint handling, SCARs to local suppliers, new customer approval, 3PL/distributor/supplier audit, and other tasks assigned by the quality manager.
Handle all 3PL &MAH manufactuer related quality issues, including but not limited to
- product deviation/NCs during product inspection, storage, delivery, labeling(if have) and goods return.
-Communicate with related divisions such as SCM, operation, customer service, TS, local suppliers and headquarter about related deviations, follow up related issues until it is closed.
-Develop monthly Deviation/NC report with analysis.
-Review related operation records and ensure compliance.
Support MAH project for assigned tasks
Approval of Suppliers/Products/customers/IFU&Labels,per GSP & GMP requirement, and related data maintainance in systems.(if required)
supplier/distributor/3PL/internal audit and other tasks assigned by the quality manager
NMPA Tacking System Maintenance.
other Quality related tasks if assigned
Minimum Requirment：
BS degree or above in the following subjects: Medical Device, Pharmaceutics, Medicine, Chemistry, Biology and any other related subjects
Very good command of written English, good command of spoken English
Very good command of MS office
Min. 3+ Quality experience in MD industry is a MUST,Production Quality Experience is a must ,experience in process validation and product design quality is a PLUS.
Comprehensive knowledge of GMP/GSP and ISO13485
Experience with SAP is preferred.
Good skills of Word, Excel, PPT and Visio is a plus.
Excellent communication skills
Good problem identification and analysis skills
Regular visit 3PL warehouse & supplier audit per planned
Able to travel if required (<30%)