·Responsible for ensuring Good Distribution Practice (GDP) is complied with for products imported and wholesaled；
·Perform Quality and compliance specific tasks including but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination；
·Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs；
·Implementing and maintaining the QMS to ensure that required processes are established and effective；
·Process owner of quality systems such as, but not limited to; internal audits/self inspection, change control, management reviews, deviation management and CAPA；
·Compile and update training manuals, undertake induction training and refresher training related to QMS for local staff；
·Ensure quality agreements are established with 3rd parties；
·Ensure 3rd parties are qualified and maintained in an approved audit status；
·Decision of disposition for trade returns and damaged products；
·Maintenance, analysis and reporting of Quality KPIs；
·Develop and manage effective working relationships with competent authority and Global colleagues；
·Foster and maintain good cross-functional working relationships with other departments; attend cross-functional meetings and represent the Affiliate where necessary；
·Represent the company in the relevant committees of the professional/industry associations, if necessary.
·Bachelor’s degree or above major in life sciences disciplines.
Work Experience :
·Must be trained in or have experience with the requirement of medical device GSP at least for 5 years；
·Certificate on ISO 13485 will be preferred；
·Medical Device GMP experience will be preferred；
·Good understanding of Quality System regulations and requirements and ability to identify opportunity for improvement and implement improvement on the existing system.
Required pre-requisites skills/experience for this position :
·Strong organization, communication and teamwork skills to be able to effectively interact within multidisciplinary groups；
·Reliable,hardworking with enthusiastic and positive attitude；
·Good knowledge of Microsoft Office Tools；
·Fluent English (oral & writing).
Behavioural Skills \行為技能：
·Customer and Brand Focus；
·Impact and Influence；
·Courage and integrity；
·Initiative and Anticipation；