深圳招聘

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this greater cause. It reflects their pioneering spirit, combined with our long history of engineering in the ever evolving healthcare industry.

We offer you a flexible and dynamic environment where you have the space to stretch beyond your comfort zone in order to grow personally and professionally. Sound interesting?

Then come in and join SSMR as 高级质量体系工程师 / Senior QMS Engineer to inspire the future of healthcare.

Your mission and responsibilities:

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. 8Dmethodology

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；

Your qualifications and experiences:

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. 5 years of experience in Quality Management；

5 年或者更长时间的质量管理经验；

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；

9. Management experience and/or leadership experience. You have leaded and you

have at experience in working in multicultural cross-functional teams.

具备管理和领导经验，且有在跨职能部门中工作的经验；

Being part of our team:

Siemens Healthineers is a leading global medical technology company. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Curious about our culture?

Our culture embraces different perspectives, open debate and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas and celebrate success.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

在西门子医疗，我们的目标是通过全面实现数字化医疗，助力医疗服务提供者在各自领域推进精准医疗、转化诊疗模式、改善患者体验，以全方位助力其提升价值。每一天，全球有五百万名患者在影像诊断、临床诊疗、实验室诊断、分子医学以及数字化医疗和企业服务方面受益于我们的创新技术和服务。

拥有超过170年历史，在全球范围内持有18,000个专利，西门子医疗是领先的医疗技术公司。我们在全球超过70个国家的48,000名员工将继续创新，塑造医疗行业的未来。

西门子（深圳）磁共振有限公司（SSMR）于2002年植根中国，是西门子医疗的独资子公司。公司位于深圳高新技术园区，建筑面积超过4.6万平方米 。业务范围涵盖MR（磁共振成像系统）、AT（临床治疗系统）以及ME (医疗组件及真空技术），是一家集研发、生产、物流、市场、客户服务于一体的高新技术企业。