北京招聘

Description - (Enter the key activities of the role)
l Review and release procedures from all functions or global function.
l Organize internal and external audits, track timely closure of the findings.
l Establish and improve Quality Management System procedures with each function.
l Establish and improve Information Security Management system procedures with each function.
l Establish and improve Environmental Management System procedures with each function.
l Train employees for process and awareness.
l Help to organizer management review meeting, including QMS,ISMS,EMS .
l Supervise CAPA to timely close and trend analysis.
Responsibilities and HIRING Requirements 职责和录用条件
To assist the managers to deploy and implement Elekta Quality Policy and Quality Directives
To identify and report any issues of concern to Q/RA management and appropriate functions.
To support the functional organizations in the implementation of effective, efficient and compliant Quality Management Systems.
To manage quality control in the manufacturing process.
To report status of ongoing development projects to QA Manager.
To do the final acceptance test of product and sign of CoC.
Function the authority to reject the product from passing to next step and provision to customers if the product can’t meet the requirement of quality, security and regulations.
Support that QS documents being upgraded timely, and meet the requirement of traceability when requested in external audit.
To promote the quality system and its principles throughout the organization.
Authorities 职权
Action delivery stop as appropriate in the event of non conformances against quality, safety, or legal requirements.
To represent Elekta QA with external
bodies .
To approve CoC after final test.
Facilitate external/internal audit relevant actions, including assignment of NCs and NCs closure
相关知识， 技能和能力要求。以上“职责和录用条件”要求之外，并要求以下：
Relevant Knowledge, skills and competEncies
Bachelor degree or above in technology or equivalent.
Familiar with quality management, at least three-year relative working experience.
Training in and experience of ISO9001
SO13485
I
ISO27001,ISO1400103 and MDD. Training in QSR is an advantage.
Qualified to Internal Auditor of national leve. l.Qualified in ISO13485, ISO14001&ISO27001 is an advantage.
Good skills in English, fluent in listening, speaking and writing.
Good command of computer, familiar with MS office
Notesoutlook and have knowledge of MRP system.
Able to work in a multi-cultural, corporate international environment.
Able to work independently.
Easy to cooperate with.
Integrity
Communicative and pedagogic skills.
Organized, able to wok with several task in parallell.

Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders.

Elekta is a high technology medical device company working with the latest technology and tools within the development of software, electronics and hardware. Our manufacturing site has recently seen major investment in the latest tools and processes required to provide an efficient manufacturing process.

Elekta was founded in 1972 by the late Lars Leksell, Professor of Neurosurgery at the Karolinska Institute in Stockholm, Sweden. Today, Elekta solutions in oncology and neurosurgery are used in over 5,000 hospitals globally, and every day more than 100,000 patients receive diagnosis, treatment or follow-up with the help of a solution from the Elekta Group.

Elekta employs around 2,500 employees globally. The corporate headquarter is located in Stockholm, Sweden, and the company is listed on the Nordic Exchange under the ticker EKTAB.
Elekta has two legal entities, one JV, and one branch organization in China with functions of R&D, Engineering, Manufacturing, Purchasing, QA/RA, and other support functions.

Legal Entities: Elekta (Shanghai) Instruments Ltd, located in Shanghai and Beijing; Shanghai Elekta Oncology Systems Ltd, located in Shanghai
Joint Venture: Elekta BMEI (Beijing) Medical Equipment Co. Ltd, located in Beijing
Branch organization: CMS Worldwide Corp. Shanghai Rep. Office, located in Shanghai. CMS is the software development division responsible for software development around the world within the Elekta Groups

Elekta’s culture values diversity. By combining different traditions and backgrounds of all our employees we can create a positive and flexible organization.

We provide the opportunity and support to enable individuals to use their competencies to develop within a global environment.

Join us, by working together we can fight serious disease and enhance quality of life.

医科达 AB （公众）公司在华独资及合资企业

医科达 AB （公众）公司是跨国性医疗技术集团，总部设在瑞典斯德哥尔摩，并在斯德哥尔摩证交所上市。医科达 AB （公众） 公司是 医科达北研（北京）医疗器械有限公司、医科达上海软件研发中心（美国希迈仕国际公司上海代表处）、医科达（上海）医疗器械有限公司、以及上海医科达放疗设备有限公司的母公司。

医科达 AB （公众）公司在华独资及合资企业主要经营放疗和神经外科两大类产品，包括直线加速器及其相关附属产品，致力于建立本地化的研发、生产和技术支持，为客户提供更完善的服务。我们在此虚位以待，邀您共创中国放疗和神经外科的未来。

公司地址
北京：北京市昌平科技园区创新路21号，
上海：上海市浦东新区世纪大道1528号 陆家嘴基金大厦5F、3F 301, 上海市浦东新区金海路1000号B1