质量工程师（QMS）

岗位概述 Position Summary
Establish and maintain a quality management systemthat meets the requirements of laws and regulations and the group, and maintain the compliance, suitablity and effectiveness of the system through continuous impovement.
建立和维护符合法规及集团要求的质量管理体系，并通过持续改进保持体系的符合性、适宜性、有效性。
Organize the internal auditand external audit of the company. Control system documents and records of the quality management system. Change control on management system and products. Support operation confirmation activities.
组织公司内部审核、外部审核。控制质量管理体系文件与记录。管理体系及产品变更控制。支持运营确认活动。
岗位职责 Responsibility
Establish and maintain the quality management system of CZM GZH in accordance with the requirments of the global medical device laws and regulations and the requirements of CZM quality system architechture;
按照全球医疗器械法律法规要求以及蔡司医疗质量管理体系架构要求，建立和维护蔡司医疗广州场地的质量管理体系；
Be responsible for tracking relevant laws and standards, and planning and organizing the activies of introducing laws and standards into the quality system ;
负责跟踪相关法规标准，并策划、组织开展法规标准导入质量体系的活动；
Managing preparation, revision, implemetation and training of the qualiity system documents;
管理质量体系文件的编写、修订、实施与培训；
Manage quality system documents and product changes to ensure that changes are implemented in accordance with the global change process;
管理质量体系文件及产品变更，确保变更按全球变更流程执行；
Organize the internal and external audit of GZM GZH quality managemetn system, promote the closure of audit findings；Continuously promote quality management improvement activites, such as corrective and preventive action;
组织公司质量管理体系内审与外审；推进审核发现的关闭；负责持续推进质量体系改进活动，如纠正预防措施；
Assist in managing operation process validatuion activies, product quality assesment, review, improvement and other quality activities, based on risk management;
依据风险管理，协助管理运营过程的确认活动，以及产品质量评价、核查、改进等质量活动；
Timely, accurate and effective communication and expression, internally and externally.
内外部及时、准确、有效的沟通与表达。
Other tasks assigned by superior.
其他上司交代的任务
学历要求 Education Bachelor's degree or above
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。
工作经验/经历 Work Experience
Not less than 4years of experience in medical device or mecical quality managementis preferred, espeically in sterile or implantable medical device, as well as experience in auditing or audited on CE, FDA & NMPA.
医疗器械或医疗质量管理经验，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。
专业知识/技能 Knowledge And Skill 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.
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。