北京招聘

职位描述：
Requirements
Education
？ University degree or above. Major in mechanical or Optic-electronics preferred.
本科以上学历，机械或光电专业优先
Experience
？ At least 3 year experience in quality system management with medical device manufacturing experience highly referred.
三年以上医疗器械工厂质量体系管理经验;
？ Proven record of QMS management, ISO standard enforcement, and quality control.
医疗器械行业质量管理体系管理，ISO 标准推行，质量控制相关经验
？ 21 CFR 820，MHLW 169，SOR/98-282，MDD93/42/EEC preferred
有21 CFR 820，MHLW 169，SOR/98-282，MDD93/42/EEC 相关经验者优先
Skills:
？ Strong sense of responsibility
责任心强
？ Excellent communication and teamwork skills
优秀的沟通能力和团队合作精神
？ Good command of English
英语熟练
？ Ability to keep clear and accurate records and reports.
制定清晰而准确的数据和报告
？ Ability to organize work load and to manage multiple tasks.
能够承担工作压力，自我管理和组织多项任务
？ ISO9001, ISO13485 and ISO14000 certified.
持有9001/14000/13485 管理体系证书

Principle Responsibilities:
？ Set up and maintain all files in accordance with operating procedures.
按照运营流程建立和维护相关的所有文件
？ Review documentation for accuracy and completeness as required.
检查文件的准确性和完整性
？ Coordinate the process for managing temporary and permanent changes to documentation.
协助处理文件的临时性和永久性调整
？ Manage the process for traceability, retention, and storage of controlled documents.
管理受控文件的追溯、保留和存储
？ Communicate clearly with all depts. to assure current, accurate documentation is accessible and in use across the organization.
与各部门保持沟通，确保文件跨部门的及时性，准确性和以获取性
？ Maintain and audit the Master List of documents to assure all revisions logged on the system are correct.
维护和审核文件清单，以确保系统中的修订版的正确性
？ Coordination and Implementation of all Activities, Procedures and Processes coming from Corporate Quality Department.
协调和执行所有来自于公司总部质量部门的活动,流程和程序
？ Coordination of all activities in regard to ensure the compliance to all relevant quality standards company Suzhou is committed too. (e.g. CFDA , FDA requirements, ISO 9001, ISO 14001, ISO 13485).
协调所有相关活动，确保相关质量标准的合规性，如CFDA，FDA 要求，ISO 9001, ISO 14001, ISO 13485

Email： grace.yuan@eagleconsulting.cn 举报 分享

We are a boutique staff selection firm specialized in automotive, electrical/electronics, chemical, mechanical, engineering sectors. Our consultants and researchers all possess active track record in the staff selection business. We have continuously and successfully served multinational and sizeable local enterprises for their recruitment needs.
 
Our market positioning is clear that we are good at identifying middle level management and professional staff. We believe that a strong middle level is the key of business sustainability and development for all companies. Our years of experience in the staff selection industry give us thorough understanding on how to match the needs of employers and the advantages of candidates. We provide “no-frills” while focused services that is time and cost effective to both employers and ourselves.
 
We are in association with Recruit Holdings; a Hong Kong listed company that operates ***************, a leading recruitment portal in Shanghai. The shared resources enable us to access to a broader spectrum of candidates.