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QMS Engineer

Company:  bioMérieux

Shanghai, CN

Job Function:  Quality
Posting date:  Jun 15, 2024

1、Safety, Health & Environment /安全,健康和安全
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.
Locally manages plan for all QMS parts in scope while maintaining a compliant and effective (local) QMS.
Administers and contributes to the management of any local QMS documents and records in document control system (livelink)or offline.
Supports training and training plan administration as the QMS and contributes to training content for local QMS documents as necessary.
Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
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.
Ensure site annual audit planning and schedule meets the requirements of internal policies and external regulations.
Responsible for QMS self-examination during product license registration and manufacture license application phrase.
4、Supplier Quality/供应商质量
Tightly working with purchasing team to management and supervision of suppliers, to make sure provided material, components, parts, services meet requirement.
Ensure supplier audit planning and schedule meets the requirements of internal policies and external regulations.
Feedback to supplier when don’t meet quality specifications, and ask supplier for investigation, follow up necessary supplier corrective actions. 
Responsible for supplier related change management.
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.

Job ID:  47101