北京招聘

DESCRIPTION - (Enter the key activities of the role) 填写职位的主要责任

Support to maintain the operation of the Elekta quality system to enable product and service, defined strategies and policies, to meet the required standards and regulatory requirements in harmony with business need.
协助维护公司质量体系的运作，确保产品和服务以及战略方针符合标准和法规的要求，并与公司业务要求保持一致。
Proactively identify and participate in process continuous improvement activities and facilitate the implementation of existing procedures and quality critierion with high efficiency.
积极主动地参与流程的持续改进，推动现有流程和质量规范的切实有效地实施。
As required, participate in cross-organisational projects and programmes to implement global business systems.
根据需要， 参与跨部门或跨公司的合作项目和规划，在全球化业务系统中发挥作用。

“RESPONSIBILITIES AND HIRING REQUIREMENTS 职责和录用条件” (Using e.g. bullet points, identify the detailed aspects and specific responsibilities of the role.

Advise and assis project managers on the implementation of an effective and economical documented quality system that meets the requirements of the business in harmony with ISO 9001, ISO 13485 and US FDA 21CFR.
协助项目经理行之有效地贯彻执行文件化的质量体系， 从而满足公司业务发展的要求并与相关标准ISO9001,ISO13485以及美国FDA21CFR 的要求保持一致。
To participate in the QA internal audit programme, including process audit; project audit; product audit; etc.
参与质量体系内部审核，包括过程审核；项目审核；产品审核；等等。
Be responsible for the implemention of Design project Quality Audit during product developing process or product maintaince process，including process audit and product audit.
负责实施研发项目或产品维护项目的质量审查，包括过程质量审核和产品质量审核。
To follow Elekta global project process, participate in related project documents review to find existing gap for improvement.
依据医科达全球化项目管理的流程，参与相关项目文件的审查，并跟踪对发现的问题的改进。
To hold quality analysis meeting for the nonconformity found in any stage of project to find out the root cause.
召开项目质量分析会议，对发现的不符合项查找根本原因。
As per project plan, check archived project records and documents, ensuring traceability.
依据项目计划，检查已存档的项目记录和文件，确保其可追溯性。
Monitoring, measuring and reporting of the quality of project process and product.
监控，测量和报告项目过程质量和产品的质量。
Training of Elekta personnel in the quality system
对医科达内部员工进行质量体系的培训
Other responsibilities which the reporting manager assigns
主管经理安排的其他工作


AUTHORITIES 职权- (Using e.g. bullet points, identify the authorities of the role and the extent to which decisions may be made on behalf of the function.)
填写职位的权力，以及由此扩展的可能结果

Preparation of audit plans, execution of quality audits and preparation of audit reports.
准备审核计划， 实施质量审核，完成审核报告。
Issuing and closure of non-compliances.
发布和关闭不符合项
Approval of Deviation Reports.
对偏离质量要求的报告的审核
Reporting to top management representative about important quality problems.
向最高管理者代表汇报重要的质量问题
Issue and change to processes and procedures
发布和更改相关的流程和程序
Get relevant training to continuously improve personnel competence
获得相应的岗位培训以不断提高个人的工作技能
Other authorities which approved by reporting manager
主管经理授予的其他权限

RELEVANT KNOWLEDGE, SKILLS AND COMPETENCIES - (For the role, specify the following: - educational background and knowledge, - details of relevant experience, - skills required for the role, - key performance competencies that are required)
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：

Takes responsibility and acts autonomously when necessary. 需要时负责任并主动行动。
Prioritizes competing tasks and projects and manages time effectively to meet deadlines.
优先考虑完成任务，有效管理时间以期在最后期限前完成工作。
Bachelor degree or above in Mechanical or Electrical Engineering or equivalent.
机械或电子工程或相关专业，本科或以上学位
Familiar with Quality management, at least three-year relative working experience.
熟悉质量管理，至少三年相关工作经历
Training in and experience of ISO9001, ISO13485 and MDD. Training in QSR is an advantage.
具有ISO9001， ISO 13485和MDD的培训和经历，接受过QSR培训者优先
Qualified to Internal Auditor of Quality Management System
具有质量管理体系内审员资质
Experience in project management
具有项目管理的经验
Good skills in English, fluent in listening, speaking and writing.
英语水平良好，听、说和写作流利
Able to work in a multi-cultural, corporate international environment.
能够在多元文化，国际合作的环境下工作
Organized, able to wok with several task in parallell
有条理性，能够同时进行多项工作
Able to work independently.Easy to cooperate with.
能够独立工作。易于合作。

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