SSMR AT 质量工程师 / Quality Engineer
西门子 (深圳)磁共振有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2020-10-23
- 工作地点:深圳-南山区
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:本科
- 语言要求:英语良好
- 职位类别:其他
职位描述
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 AT 质量工程师/ Quality Engineer as to inspire the future of healthcare.
Your mission and responsibilities:
1.Need strong quality baseline and rich coach and influence skill to guide the high quality SCM output and always need to overcome the challenges from limited resource and boundry of responsibilities( from personal and department )with experienced constrctive solutions, 需要坚守质量底线,通过丰富的指导和影响力来确保生产输出的高质量,常常需要克服由有限的资源和个人以及部门责任边界所带来的挑战,并且需要提出建设性意见的能力。
2.Make sure the high quality output of product and records from SCM and supplier and compliance with related regulation and standards and success of audit; 确保SCM和供应商高质量的产品和记录输出,确保生产活动和供应商的输出满足相应法规和标准的要求,并确保审核的成功。
3.By coach, mainreview, training, review, communiation, influence, and other necessary skills to the SCM teams , to make sure the high quality output of products(including documents and records) and make sure the product compliance with related regulation, standards and customer requirements,and signature and release of product and process ECO as independent controller.; 通过对SCM 的指导,培训,审核,主评审,沟通,影响和 其它需要之方法, 以实现SCM高质量的产品输出(包括文档和记录),同时确保产品对法规、标准和客户要求的满足, 并作为独立监管员签署并发布放行产品和生产过程的变更。
4. Be responsible for product deviation and NC control as indepent controller; 作为独立监管员负责产品偏差和不合格品的管理;
5. Timely tracking SCM and supplier related regulation( at least including ISO 13485, ISO 9001,QSR 820,China GMP,Australia TGA 1989 and 2002,Brazil ANVISA RDC16/2013,Japan MHLW NO.169 , Canada CMDR ,EU MDD, MDR), analysis and planning of implementation and lead implementation; 及时跟踪全球生产和供应商相关法规(至少包括ISO 13485, ISO 9001,QSR 820,China GMP,Australia TGA 1989 and 2002,Brazil ANVISA RDC16/2013,Japan MHLW NO.169 , Canada CMDR ,EU MDD, MDR), 分析并制定执行计划并领导导入计划的执行;领导并实现高水平的全生命周期的产品质量和供应商质量,例如,通过有效的方法(如 FMEA、APQP, CAPA, 5W, etc)及识别和控制内部和供应商关键质量过程
6. Establish, maintain and optimize SCM and supplier related process 建立、维护和优化SCM和供应商相关的程序;
7. Training management 培训管理
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 ;
- EU MDD, MDR;
2. 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;
3. Fluent English 流利的英文听说读写能力
4. At least 3 years experience in Quality Management 3年或者更长时间的质量管理经验;
5. Multiple experience of internal and external QMS audits, including ISO 13485, MDD or FDA audit 具有多次参与公司内外审的经验, 包括ISO 13485, MDD和FDA 审核。
6. 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.
公司介绍
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。
联系方式
- 公司地址:西门子磁共振园