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QMS Engineer - Shanghai, 中国 - bioMérieux
描述
1、Safety, Health & Environment /安全,健康和安全
确保符合总部EHS方针、本地法规以及ISO14000的需求。
Ensure compliant to global EHS policy, local regulation and ISO 14000 requirements.
2、Quality Management System/质量管理体系
确保遵守国家药品监督管理局相关法规、ISO 13485 标准以及其他适用行业规范,以支持完成公司目标。
Support the company's goal of ensuring compliance with NMPA regulations, ISO 13485 standard and other industry codes applicable.
负责本地范围内所有质量管理体系的管理计划,同时保持合规且有效的(本地)质量管理体系。
Locally manages plan for all QMS parts in scope while maintaining a compliant and effective (local) QMS.
作为管理员负责管理文件控制系统(livelink)或线下的任何本地质量管理体系文档和记录。
Administers and contributes to the management of any local QMS documents and records in document control system (livelink)or offline.
支持质量管理体系相关培训和培训计划,并根据需要为当地质量管理体系文件提供培训内容。
Supports training and training plan administration as the QMS and contributes to training content for local QMS documents as necessary.
发展专业知识,应用公司政策和程序来解决各种问题。
Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
3、Audit/审核
支持工厂、集团质量以及监管当局的良好生产规范和ISO 9001/ISO 13485质量体系等审核活动,包括与监管当局的沟通工作和整改措施的跟踪。
Supports site, corporate and competent authority quality system audit activities of GMP and ISO 13485 etc. including communication with competent authority and follow up mitigate actions.
确保工厂年度审计计划和时间表符合内部政策和外部法规的要求。
Ensure site annual audit planning and schedule meets the requirements of internal policies and external regulations.
负责工作产品注册以及生产许可申请期间的质量管理体系自查
Responsible for QMS self-examination during product license registration and manufacture license application phrase.
4、Supplier Quality/供应商质量
与采购团队紧密合作,对供应商进行管理和监督,确保其提供的材料、组分、部件、服务等满足要求。
Tightly working with purchasing team to management and supervision of suppliers, to make sure provided material, components, parts, services meet requirement.
确保供应商年度审计计划和时间表符合内部政策和外部法规的要求。
Ensure supplier audit planning and schedule meets the requirements of internal policies and external regulations.
在不符合质量规格时向供应商反馈,并要求供应商调查,以及跟踪必要的供应商纠正措施。
Feedback to supplier when don't meet quality specifications, and ask supplier for investigation, follow up necessary supplier corrective actions.
负责供应商相关的变更管理。
Responsible for supplier related change management.
依据工作需要出差。
Business trips per work needs.
本科及以上学历,机械,电子,生物工程、医学工程等医疗器械相关专业,需要有至少3年以上的有源医疗器械研发或生产企业相关工作经验。
Bachelor degree or above, major in active medical devices such as mechanics, electronics, bioengineering, medical engineering, etc. and necessary to have at least 2 years of relevant work experience in active medical device R&D or production companies.
语言技能:英语和中文听、说、读、写熟练,有欧美外资企业工作经验者优先。
Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese, applicants with working experience in European and American foreign-funded enterprises will be given priority.
能熟练操作Word和Excel等办公软件,熟悉Livelink系统者优先。
Proficient in operating office software such as Word and Excel, candidates familiar with SAP will be given priority.
有良好的团队合作能力。
Good Interpersonal skill and team player.
熟悉ISO 19001, ISO 13485, IS14971, GMP等医疗器械及生物安全等相关的法规规范,且必须有ISO13485内审员证书。
Be familiar with relative medical device regulation and bio-security and other codes, such as ISO 19001, ISO 13485, ISO 14971 and GMP, candidates with ISO13485 internal auditor certificate is mandatory.
