工作职责： Responsibilities (fundamental job duties): 负责质量管理体系的建立和维护，以符合FDA QSR, ISO13485及欧盟医疗器械指令的要求。 Be responsible for the establishment and maintenance of the quality management system, which is in compliance with FDA QSR, ISO 13485 and MDD 93/42 EEC. 定期向管理层报告质量管理体系的运行情况。 Report to top management, at a regular basis, the performance of the quality management system. 负责供应商质量管理。 Be responsible for supplier quality management. 负责产品放行的批准。 Be responsible for approval of product acceptance. 负责组织不合格品评审。 Be responsible for nonconforming product review. 根据技术规范的要求，制订新产品的质量标准。 Base on the technical specification, set up quality standards and specifications for new products. 负责准备和协调与质量管理体系有关的审核或检查。 Be responsible for the coordination and preparation of external audits or inspections to quality management system. 负责纠正预防措施的实施和验证。 Be responsible for the implementation and verification of corrective and preventive actions. 负责与质量管理体系有关的数据分析。 Be responsible for quality management system related data analysis. 负责客户抱怨的处理。 Be responsible for customer complaint handling. 负责质量管理体系的策划。 Be responsible for quality management system planning. 负责产品设计开发的评审， 风险管理和更改控制。 Responsible for product design and development review, risk management and change control. 参与过程确认。 Participate in process validation. 参与质量管理体系内审和管理评审。 Participate in quality management system internal audit and management review. 工作胜任要求： Minimum Requirements: 本科以上学历； Bachelor degree or above; 5年以上质量管理体系运行经验，一次性医疗器械或塑料制品行业工作经验优先; 5 years relevant experience in quality management system, with experience in single use medical device or plastic products industry is a plus； 国家注册质量工程师优先； China Registered Quality Engineer is a plus; 具有ISO9001/ISO3485/ISO4001 内审员资格优先； ISO9001/ISO13485/ISO14001 internal auditor is a plus; 较强的领导力； Strong leadership; 良好的口头及书面沟通能力； Good communication skills (both verbal and written); 中英文流利。 Be proficient in both English and/or Mandarin Chinese.