岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
作为质量保证主题专家提供指导和专业知识
Serve as quality assurance (QA) subject matter expert (SME) to provide guidance and expertise
主要职责 / MAIN ACCOUNTABILITIES
提供质量专业知识，以符合当地医疗器械法规和相关标准。
Provide quality expertise to compliant to local medical device regulations and relevance codes.
负责生产过程的质量监督，包含首件检查、包装前清场检查，成品目视抽检及批记录的审核，日志簿审核，成品放行等，确保产品质量符合产品注册技术要求。
Responsible for the quality supervision of the production process, including the first article inspection, pre-production area clearance inspection visual inspection of finished products, batch records review, logbook review and release of the finished goods etc. Ensure that the product quality meets the technical requirements as product registration.
负责缺陷品管理，质量QA文件归档以及QA程序文件的周期性回顾
Be responsible for the defect sample management, quality documentations’ archiving and periodic review of the procedures.
作为质量保证主题专家，根据法规和公司内部质量体系要求进行质量事件、原因调查、纠正和预防措施和质量变更控制的协调和评审。
Serve as QA SME to coordinate and review quality event (QE), cause investigation (CI), CAPA and quality change control per regulations and company internal quality management system requirement.
根据需要支持内部和外部的审核活动。
Supporting internal and external audit activities as necessary.

*.履行由公司规程规定或由直属上级指派的其他任务。Other tasks as defined in related company procedure, or assigned by the direct supervisor.
备注：公司赋予员工履行上述职责所需的权力。
Notes: Required authority will be provided to implement responsibilities listed above.
职位要求：
知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
大专及以上学历，制药或医疗器械科学/工程或其他相关专业。至少5年以上医疗器械或制药行业工作经验，2年以上质量保证经验。
Colleague degree (equivalent) or above. At least 5 years’ experiences on medical device or pharmaceutical industry. At least 2 years’ experience as QA role.
熟悉GB/T 42061 (ISO 13485) 及其他质量管理体系相关的法规及标准，有内审员证书为佳。
Familiar with GB/T 42061 (ISO 13485) and other quality management system related regulations and standards, preferably with an internal auditor certificate.
熟悉医疗器械良好生产规范，包括但不限于《医疗器械生产质量管理规范现场检查指导原则》、《医疗器械生产质量管理规范》及其相关附录。
Familiar with quality good manufacture practice, including but not limited to "Guiding Principles for On-site Inspection of Good Manufacturing Practice for Medical Devices", "Good Manufacturing Practice for Medical Devices" and their related appendices.
良好的英语理解能力。
Understand English well.
熟悉精益和六西格玛质量方法论为佳。
Familiar with Lean and six sigma quality methodology is as better.