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当前位置:首页 > 医科达北研(北京)医疗器械有限公司 > 设计控制质量工程师Quality Engineer for Design Control
设计控制质量工程师Quality Engineer for Design Control

面议

北京 毕业生本科 品质管理

2024-04-18发布

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

医科达北研(北京)医疗器械有限公司

200-500人

10个在招聘职位

北京-昌平科技园区创新路21号

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