质量工程师

岗位概述 Position Summary
Control of quality compliance on product in targeted countries and regions piror to marketing
产品在目标国家和地区上市前的产品质量合规性管控 Responsible for quality assurance and related tasks in the new projects releated product.
负责新产品项目的质量保证等相关工作
岗位职责 Responsibility
Partipate in project meeting ，promote efficient on-time output and input bewteen project team and department.Participate in the project process as a representative of the quality department to review activities related to product quality and system compliance, ensuring that all activities within the project process comply with medical device regulations.
参与蔡司医疗项目会议，并积极促成项目团队和部门间的及时有效的输出以及输入。参与项目过程，作为质量部门代表对项目过程中的各项与产品质量和体系合规相关的活动进行审核，确保项目过程中的各项活动符合医疗器械相关法规的要求。 Organize and lead key compliance activity managed by the quality department, especially when triggered by CZM GZH as registered agent, e.g. registreation type test， biocompatibility study.
组织并主导质量部门负责的关键合规性活动，特别是其中有关蔡司医疗广州场地做为注册代理人时， 如注册检验， 生物相容性研究。 Based on projects of product program, develop quality compliance developing activities,e.g. identification of laws, regulatories, standards and requirement, gap analysis，follow up of the registration management system establishment and improvement , etc.
按产品有关的项目策划，开展有关注册管理体系管理的相关工作，如法律法规标准要求的识别,差距分析,跟进注册管理体系的建立和改进等。 Responsible for managing product technical requirements and following up on and implementing type testing, such as translating and proofreading product technical requirements, handling feedback from relevant authorities, etc.
负责管理产品技术要求以及型式检验的跟进和落实，如产品技术要求的翻译和校对，有关当局反馈的处置等 Participate in the design and development review process for newly introduced products, e.g. coordinating and following up on the development of methods for incoming inspection and finished product inspection, Risk identification and review of control measures for product processes, etc.etc.
参与新引入产品的设计和开发评审流程，如进货检验，成品检验的方法开发的协调和跟进, 产品工艺的风险识别和控制措施审核等 Coordinate and follow up on the development and completion of test methods or research plans related to product quality compliance, such as the development of methods for incoming inspection and finished product inspection, stability studies, etc.
协调和跟进产品质量合规性有关的设计转移活动，如进货检验及成品检验的方法确认，稳定性研究等。 Partipate in ZEISS Meditech internal technical communication，promote efficient on-time output bewteen global and site.
参与蔡司医疗内部技术交流会议，并积极促成集团和本地工厂的及时有效的输出。 Partipate in external technical communication and promote efficient on-time output bewteen ZEISS Meditech and appropriate authority which impacts compliance of product quality .
参与外部技术交流，并积极促成蔡司医疗与影响产品质量合规性的有关当局之间的及时有效沟通。 Perform other task assigned by superior
完成上级交代的其它工作任务
任职资格 Qualification
本科学历及以上 专业要求Major Clinical Medicine, Biotechology, Pharmaceuticals, Regulatory, English, and similar applicable majors.
临床医学、生物技术、制药、法规、英语等相关专业。
over 3 years of experience in quality management, quality control, or quality project management in the medical device or pharmaceutical industry, with preference given to experience in sterile or implantable medical devices. Experience in handling CE, FDA, or NMPA system audits is preferred.
具有3年以上医疗器械或医药行业质量管理、质量控制或质量项目管理相关经验，尤其是无菌或植入式医疗器械方面经验优先，有应对CE、FDA、NMPA体系核查工作经验优先。 Have some knowledge related to quality inspection or experience on QC Lab, and be familiar with inspection processes, inspection techniques, and relevant regulatory requirements.
有一定的质量检验相关知识或实验室工作和管理相关经验，了解基本检验过程和检验技术。 Familiar with the requirements of legal and regulatory and standards in pharmaceutical industry.
熟悉医药行业法律法规标准相关要求。
专业知识/技能 Knowledge And Skill English level 4 or above. The avility to communicate in English and Mandarin, in both written and verval form is essential.。A high level of skill in using Microsoft softwarem especially Excel.
英语4及以上，能够用英语和普通话以书面和普通形式进行交流是必不可少的。熟练使用 Microsoft 软件，尤其是 Excel。 Comprehensive experience to use tools and methods for Quality Management and Quality Control.
使用工具和方法进行质量管理和质量控制的综合经验。 Able to utilize quality tools (such as fishbone diagrams, checklists, control charts, etc.) and proficient in using CAD, UG, WORD, EXCEL, PPT, and other office and professional software.
能运用质量工具（如鱼骨图，检查表，控制图等），能熟练使用CAD、UG、WORD、EXCEL、PPT等办公及专业软件