Core Mission QA specialist is responsible for maintaining medical device GSP. Work Environment & Key Data Location : China / Shanghai Reporting : Reports to the senior QA manager Requirement Technical Skills : Education/Training : ？ Bachelor’s degree or above major in life sciences disciplines Work Experience : ？ Must have 2+ year experience in Medical Device quality system, GSP experience is preferred ？ Must have experience in complaints handling ？ Certificate on ISO 13485 will be preferred. Required pre-requisites skills/experience for this position : ？ Reliable, hardworking with enthusiastic and positive attitude. ？ Good knowledge of Microsoft Office Tools ？ Good English at least in writing Behavioural Skills : 行为技能 ? Achievement ? Customer and Brand Focus ? Impact and Influence ? Cooperation ? Courage and integrity ? Initiative and Anticipation ? Innovation

Duties and Responsibilities ？ Complaints Being the coordinator between global QA and customers to ensure timely reporting and investigation result delivered. Follow up return sample status and investigation status. Translate investigation report. ？ Customer qualification management Customer qualification and requalification check and approval in system ？ Vender management Ensure quality agreements are established with LSO and distributors. Audit LSO warehouse to ensure quality agreement has been implemented. ？ Undertake induction training and refresher training related to QMS for local affiliate staff ？ Monitor and document destruction of returned product ？ Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs or updated regulations ？ Internal audit and deviation follow up ？ Maintenance, analysis and reporting of Quality KPIs

职能类别：药品生产/质量管理

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