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助理質量經理/ 高級質量專員 8+ 千/月/月

碧迪醫療器械（上海）有限公司

上海

本科
03-02 發布

職位信息

職位名稱：助理質量經理/ 高級質量專員

類別名稱：

職位描述：

職位描述：POSITION SUMMARYThe position is also responsible for maintaining the company’s quality systems including the trading company systems, supply chain and distribution center quality management, supplier management, etc. He/she is to ensure that the quality system compliance requirements are met per the corporate and local regulation requirements.KEY RESPONSIBILITIES1.Responsible for maintaining the company’s quality systems and the quality management in the distribution center and supply chain, including supplier audit, etc.;2.Responsible for Control of Documents and Records and ensure that the quality system documentation, forms and records comply with all applicable standards and regulations;3.Responsible for review and update when necessary the BD’s quality documents in accordance with quality related laws and regulations etc.;4.Responsible for disseminating quality procedures and scheduling and tracking associated training;5.Responsible for the Nonconformance procedure management and follow up;6.Responsible for collecting, trending and disseminating quality indicators, including but not limited to quality objectives, service levels, distribution, training and complaints;7.Initiate, track, follow-up and close Corrective and Preventive Actions;8.Co-ordinate, schedule and follow-up Management Reviews and site audits;9.Other related work assigned by the manager.SKILLS AND ABILITIES1.At least 3 years’ quality assurance experience in the pharmaceutical or medical device industry;2.Relevant experience in quality systems for failure investigation, corrective & preventive action, and quality document & record management;3.Experience in trading company, supply chain/warehouse quality systems;4.Fluent in spoken and written English;5.Good communication skills;6.Teamwork;7.Drive for results and action oriented with a high sense of urgency.DESIRABLE1.Familiar with the CFDA quality system requirements, e.g. AE reporting, recall regulation, GSP, labeling requirements for the imported medical devices etc.;2.Knowledge in ISO 9000:2008, ISO 13485:2016 or US FDA QSR will be an advantage;3.Good English communication skills, computer skills, excel, Access, PowerPoint etc.

任職要求：

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