上海招聘

* Participate in developing supplier quality manual. 

* Maintain data in Approved Supplier List (ASL) 

* Perform supplier qualification audits and lead supplier qualification process. 

* Work integrated with product development (US and Sweden) in NPI projects 

* Support business with supplier quality analysis and suggestions for improvement also for quality issues related to product design. 

* Perform production process design. production process validation and part approval 

* Develop and perform training for employees (sourcing) and suppliers. 

* Monitor performance from the supplier base and lead supplier improvement projects 

* Participate in CAPA projects.

* Solid knowledge in Quality Management System

* Solid knowledge in design, production engineering and production methods 

* General knowledge in compliance regulations for medical device industry

Preferably holds a professional certification through accrediting organizations, related to: 

* Quality Management Systems 

* ISO 13485 Quality System for Medical Device 

* Regulartory requirement CFR 820 issued by Food and Drug Administration in USA.  

* Regulatory requirement EU Regulation 2017/745 issued by the European Union