职位描述

职位描述： ResponsibilityYou will be responsible to define quality system, guide and supervise the implementation, to ensure company complies with applicable RD Quality Standards and local regulatory requirements, to ensure the regulatory and Company SOP compliance in QA system and business activities.制订适合的公司质量管理制度，指导、监督制度的执行，确保公司符合总部的质量标准和当地质量法规要求。确保质量管理体系和经营活动符合当地法规要求和公司内部操作规范。- Coordinating with relevant departments on regulatory and quality controlling, responsible for the execution and controlling of corrective and preventive management system (CAPA) to ensure compliance with RD quality standards and local regulations. Maintaining risk management system via quality tools, incl. fish bone, FMEA, etc. 与相关职能协调处理质量法规控制工作，负责纠正与预防措施体系的实施与控制，确保符合相关当地法规要求和总部质量要求。维护质量风险管理体系，熟悉鱼骨图、FMEA等质量工具- Conducting the audit related affairs, including internal audit, CFDA authority audit and 3rd party audit; 执行 审计相关事务， 包括内部审核， CFDA监督审核 及第三方审核 - Implementation of affiliate related divisional quality procedures and local documents. Following up of documentation local applicability and deployment; 执行总部质量文件及本地程序，并负责跟踪本地的文件适用性。- Organizing management review, responsible for analysis and monitoring of management review input data; 组织管理评审，对管理评审相关数据进行分析及监控。- Establishing and maintenance of change control process, evaluating and ensuring the regulatory and quality compliance of Changes; 建立并维护变更控制流程，评估、保障相关变更的法规与质量的符合性。- Implementing quality related training activities, complying with GxP/ISO13485 requirements. 执行质量相关的培训活动，以满足GxP/ISO13485的要求。Qualification You should hold:- Bachelor degree or above, subject on clinical laboratory/Medical/bioengineering/ biochemistry; licensed pharmacist or clinical laboratory technician-in-charge preferred; 大学本科以上学历，临床检验/医学/ 生物工程/ 生化专业。具有执业药师或主管检验师职称优先。- Proficiency in both spoken and written English and good command of MS office software application; 熟练掌握英语口语及书面表达，熟练应用微软办公软件- Understanding medical device and IVD regulation. 了解医疗器械及体外诊断试剂相关法规You should have above 3 years' experience, especially in QA management, GSP and ISO 13485 certification, keep good relationship with authorities and officials. 3年以上工作经验，有质量管理和GSP, ISO13485认证方面的经验,与相关政府部门关系良好 职能类别： 医疗器械生产/质量管理 质量管理/测试工程师(QA/QC工程师)

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