设计控制质量工程师Design Control QA
医科达(上海)软件研发中心
- 公司规模:50-150人
- 公司性质:外资(欧美)
- 公司行业:计算机软件
职位信息
- 发布日期:2014-07-15
- 工作地点:北京-昌平区
- 招聘人数:若干
- 工作经验:一年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:质量管理/测试工程师(QA/QC工程师) 医疗器械生产/质量管理
职位描述
一、工作职责
(一)生产方面:
1. 实施制造过程质量审查。
2. 对生产过程中的产品进行年度的产品审核。
3. 最终检查和放行产品,并发放验收合格证。
4. 参与NCR调查和管理。
5. 参加关于生产的零件和产品质量不符合分析的会议。
6. 获取最终检测的测试记录和检测报告,确保可追溯性
7. 监控,测量和报告生产过程和最终产品的质量
8. 对部套件进行抽样检测和管理其检测结果。
(二)质量体系方面:
1. 协助质量经理建立并控制医科达质量体系的运作,以便产品和服务,确定的战略和方针符合标准和法规的要求并于公司业务要求保持一致。
2. 积极识别持续改进的机会,并采取直接改进的行动,以达到改进的效率,保障法规和医科达QA/RA的优先项目和业务需求保持一致。
3. 协助质量经理促进医科达程序的改进和发展,着重于计量器具的校验管理和客户反馈的处理程序。
4. 向最高管理者代表汇报重要的质量问题。
5. 协助并促进公司在各个部门的质量体系和程序的发展。
6. 与相关人员一起实施质量体系内部审核。
7. 对医科达人员进行质量体系的培训
8. 负责校验程序和计量器具的校验管理, 以及生产设备和工装夹具的管理。??
9. 管理和组织CFR调查,以及主持公司内部CFR会议。
Manufacturing:
1. Carry out the Manufacturing Quality Audit
2. Carry out product audit annually for all products in manufacturing process.
3. Final check and release of manufactured products, and issue of Certificate of Acceptance.
4. Support NCR investigations and administration.
5. Member of nonconforming and quality analysis meeting for produced parts and products.
6. Archive test records and test reports for final inspections, ensuring traceability.
7. Monitoring, measuring and reporting of production process and the quality of finished products.
8. Carry out sampling test for sub-assemblies and administer the results.
Quality system:
1. To support Quality Manager to establish and manage the operation of the Elekta quality systems to enable product and services, defined strategies and policies, to meet the required standards and regulatory requirements in harmony with business need.
2. To proactively identify continual improvement opportunities and direct improvements activities achieving improved effect and securing regulatory compliance in alignment with Elekta QA/RA priorities and the business needs.
3. Assisting the Quality manager to facilitate continuous improvements and development of Elekta process with focus upon Calibration and CFR procedure.
4. Reporting to top the management representative about important quality problems.
5. To support and facilitate the company organization in the development of the quality system and processes in respective department.
6. To participate in the Internal Audit of QMS together with related person
7. Training of Elekta personnel in the quality system.
8. To administrate the calibration process and the administration of the measuring devices , and production equipment and jigs.
9. Administration of CFR investigations and organization of CFR meetings
二、任职要求
1.英语熟练
2.熟练使用办公软件MS Office
3.较强的学习能力、沟通表达能力、责任心、团队合作精神
公司介绍
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
联系方式
- 公司网站:http://www.elekta.com
- 公司地址:上海市浦东新区世纪大道1528号 陆家嘴基金大厦5F、3F 301
- 邮政编码:200122