无锡招聘

Mission of function

- Ensure implementation and controlling of quality gates and preventive quality tools to gain a sustainable higher quality in R&D processes/projects. Initiate continuous improvement with employee support. This requires personal involvement in R&D processes and projects.

通过质量关和预防性质量工具的实施和控制，确保研发过程/项目中的可持续性高质量。通过员工参与来激发持续性改进，尤其是在研发过程和项目中的个人参与。

Contacts (internal / external)

Internal:

- Line managers (部门经理)

- Colleagues in QM department (质量部同事)

- Colleagues in SPR department (采购部同事)

- Colleagues in PLM department (研发部同事)

- Colleagues in SCM department (生产部同事)

- Colleagues in CV QM (总部质量部同事)

External:

- SFDA (药监局)

- Customers (客户)

- Auditors (审核员)

Task

1.As the independent quality representative to guide the product/project development in alignment with organizational Quality Management System policy and government regulations；

作为独立的质量代表对产品/项目的开发进行指导，使其符合组织质量体系和政府法规的要求；

2.Improve the project quality via timely disclosure of quality problems in efficient quality reviews and suitable risk evaluation；

通过组织高效的项目评审及时发现项目质量问题，进行风险评估，提高项目开发过程质量，并保证最终交付的高质量；

3.As an experienced mentor to guide project/product engineers in establishing and optimizing engineering documentation archived in DHF in accordance with PEP (product engineering process；

作为经验丰富的导师来指导项目经理和产品经理创建和完善设计历史文档，使其满足规定的开发流程的要求；

4.Assist to ensure the products designed, developed and manufactured in compliance with domestics and international standards requirements；

协助保证组织设计，开发和生产的产品满足国际国内标准的要求；

5.Coach design transfer and further guide the establishment of documentation in DMR (device master record)；

主导设计转换，并进一步指导产品制造性文档的建立；

6.Participation in internal audits and external audits for good practice sharing

参与到内审与外审的活动中以求经验共享；

Knowledge

1.Regulation and laws in China, North America, European countries, Japan (中国，北美，欧洲，日本医疗器械相应法规)；

2.IEC 60601 family and corresponding Chinese standards (IEC 60601族及中国等同采用标准)；

3.CV QP/TP, SXVT-QP, CV Process House (组织内部质量体系程序与流程)；

4.Project Management (项目管理)；

5.Internal and External Audit Skill (内审外审技巧)；

6.Intercultual knowledge (跨文化知识体系)；

7.Risk mgmt and FMEA (风险管理和失效模式与影响分析)；

Experience

1.At least 3 years experience focus in R&D area or R&D quality area；

至少三年的研发或研发质量经验；

2.Project management experience and strong leadership in project management；

具有项目管理经验以及出众的领导能力；

3.Organizational spirit and good ability in problem-solving & priority setting；

出众的组织技巧以及解决问题和统筹优化的能力；

4.At least two years' experience with a JV or wholly foreign owned company;

Effective team interpersonal skills and the ability to work effectively within diverse cultural environments；

至少两年合资企业或外资企业工作经验，能够有效地在跨文化环境中工作；

Education and Language

- Bachelor or above in engineering or scientific discipline;

- Good command of both written and spoken Mandarin and English;

- Personality of carefulness, cautiousness and patience; capable to understand new concepts fast; Analytical & creative thinking

理工科本科及以上学历；中英文流利；个性谨慎仔细耐心；擅于接受新事物新概念；强悍的分析能力和创造性思维；

Capabilities

- Business Results Orientation

- Change Management

- Collaboration Influencing

- Team Development

　　西门子爱克斯射线真空技术（无锡）有限公司（SXVT）成立于2003年06月，隶属于西门子医疗集团，是西门子中国有限公司（SLC）的全资子公司。我公司是西门子在德国本土之外唯一一家医用X射线管及管组件的专业生产厂家。

　　目前，我公司主要从事产品的制造与销售。我们为OEM合作伙伴以及西门子医疗集团的内部客户提供各种高品质的医用X射线诊断用产品。

　　经历了巨大的增长，现公司要在无锡取得进一步发展，并加强研发；不仅为中国市场开发自己的产品，也要引领世界市场。我们的目标很明确，在未来五年内，生产倍增，使公司成为世界范围内最大的X射线管厂家。