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SSMR MR 质量体系工程师 QMS Engineer

Job Description

Responsibility:
1. Timely track global QMS related regulation, analysis and planning of implementation and lead implementation; 及时跟踪全球各国质量体系相关法规, 分析并制定执行计划并领导导入计划的执行。
2. Organize and lead external audit, including FDA, CFDA, MDSA audit, NB audit, etc.
组织并领导外部审核,包括 FDA, CFDA, MDSA audit, NB audit, etc.
3. Organize internal audit and management review and follow up corresponding actions.
组织内审和管理评审,并对其产生的任务进行跟踪直至改善完成;
4. Establish, maintain and optimize management related process, at least including audit, management review, document management, quality manual, process indicator, role description, training, statistics, NP software validation, outsource etc.
建立、维护和优化管理相关的程序,至少包括:审核,管理评审,文件控制,质量手册,过程监控,角色定义,培训,NP软件确认,外包控制
5. Coordination of and contribution to solve quality problems according to e.g. 8D-methodology and drive projects to solve the problems sustainably.
依据质量方法(例如:8D)持续推动项目进行,协调解决质量问题;
6. Coach the corresponding team, as the quality mentor and give fully support for all team members.
作为质量导师,指导相关团队,全力支持团队成员;
7. Draft communication and confirm agreement with external party and internal supplier;
起草并制定与外部机构和内部供应商之间的协议;
8. Training of internal colleagues with the target to get a solid performance.
培训内部员工,使他们获得良好的表现;

Requirement:
1. Good knowledge on QMS related regulation and standards and have experience to implemented into QMS, at least including /具备丰富的质量体系相关法规和标准的知识,并且具备将之导入质量体系的经验,至少包括以下法规:
ISO 13485, ISO 9001;
QSR 820;
China GMP;
Australia TGA 1989 and 2002;
Brazil ANVISA RDC16/2013;
Japan MHLW NO.169 ;
Canada CMDR ;
EUMDD, MDR;
2. Familiar with of MD standards - ISO14971, 60601,80002-2,etc.
熟悉医疗器械相关的法规如- ISO14971, 60601,80002-2,etc.
3. Have solid experience in application of Q-methods and statistics, e.g. SPC, FMEA, APQP.
具备丰富的质量方法和统计(例如:SPC、FMEA、APQP 等)应用经验;
4. Expert on use quality tools to do and coach to identify root cause, eg.5W, fish bone and drive for improvement.
能熟练运用质量工具来识别根本原因,如5WHY,鱼骨图并驱动改善;
5. Fluent English
流利的英文听说读写能力
6. Five years of experience in Quality Management System;
5 年或者更长时间的质量管理体系经验;
7. Have experience of FDA audit, CFDA audit MDSAP audit and Notify body audit, and at least as main contribution and preparation.
有经历FDA,CFDA,MDSAP 和公告机构等审核的经验,并且至少作为主要的准备和审核应对者。
8. Multiple experiences of internal audit and management review independently.
多次独立进行内审和管理评审的经验;


Organization: Siemens Healthineers

Company: Siemens Shenzhen Magnetic Resonance Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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