岗位职责：

• 负责质量体系文件控制系统的维护和改进，并负责就文件控制电子控制系统事宜与总部相关人员进行联系。
• 负责质量管理体系内变更控制系统的维护和改进。
• 协助QA经理根据新法规的要求和公司情况对体系文件进行持续改进。对公司体系运行中的质量数据进行定期整理和统计分析
• 组织和协调公司GMP培训计划的制定和实施。
• 协助QA经理制定内审计划，组织协调质量管理体系内部审核。
• 协助QA经理跟进质量目标的实现情况，组织管理评审，并定期分析和跟进改进事项。
• 组织对不合格的评审、原因分析，制定纠正和预防措施，监督纠正和预防措施的实施情况。
• 与质量管理体系相关的政府工作的跟进等，包括抽样送检，许可事项申报，年报等。
• 组织协调外部审核时的各项工作。
• 协助并参与其他分配的质量管理工作。
  

• Responsible for the maintenance and improvement of the document control system, and also responsible for contacting the relevant personnel at global for management of electronic document control system.
• Responsible for the maintenance and improvement of the change control system within the quality management system.
• Assist QA manager to continuously improve the quality management system according to the requirements of the new/updated regulations and company requirements. Regularly organize and statistically analyze the quality data in the operation of the quality system.
• Organize and coordinate the development and implementation of the company's GMP training program.
• Assist QA manager to develop internal audit plan and coordinate internal audit of quality management system.
• Assist QA managers in following up quality objectives achievement, organizing management reviews, and regularly analyzing and following up issues.
• Organizing the reviewing and root cause analysis of nonconformity, develops corrective and preventive actions, and supervises the implementation of corrective and preventive actions.
• Follow up government work related to the quality management system , including sampling and inspection, licensing matters, annual reports, etc.
• Organizing and coordinating the work of external audits.
• Assist and participate in other quality management tasks assigned.
  

任职要求：

• 本科及以上学历。 主修化学、制药、生物、生物化学，等相关专业。
• 熟练使用Office办公软件，包括Outlook、WORD、EXCEL、Power Point、Project等。
• 熟悉医疗器械监督管理的法律法规、规章规范和所经营医疗器械的相关知识、ISO13485标准、医疗器械的风险管理(ISO 14971)等，最好有CE、FDA认证经验。
• 在医疗器械行业质量管理体系岗位至少3年工作经验，有一定管理经验。
  

• Bachelor degree and above.Major in Chemistry, Pharmaceuticals, Biology, Biochemistry, Medical Devices related and etc.
• Proficiency in Office software, including Outlook, WORD, EXCEL, Power Point, etc.
• Familiar with the laws and regulations of medical device supervision and management. Familiar with ISO13485 standards, risk management of medical devices (ISO 14971) and etc., CE and FDA experience is preferred.
• At least 3 years working experience in the quality management system of the medical device industry, with certain management experience。

上班地址：深圳市南山区高新工业村R3-B-6F、7F