该职位来源于猎聘 Job Duties
- 负责产品开发/变更的整个设计开发生命周期的质量管理工作,与研发部门有效配合开展质量活动,确保项目符合相关法规和标准要求。 Responsible for the quality management of the entire design and development lifecycle of product development/changes, effectively co-operating with R&D department to carry out quality activities and ensure that the project meets the requirements of relevant regulations and standards. 2. 负责设计和开发相关过程质量管理体系文件的维护和更新。
Responsible for maintaining and updating the quality management system documents for design and development related processes.
- 协助研发部门进行部分DHF文件的撰写工作,并审核所有设计开发资料。 Assist R&D department in writing some DHF documents and review all design and development materials. 4. 负责识别设计和开发过程中的质量问题,改进研发工作流程。并负责研发阶段质量问题追踪,负责过程和产品的特性数据收集,并开展数据分析。 Responsible for identifying quality issues in the design and development process and improving the R&D workflow. And responsible for quality issue tracking in R&D phase, responsible for process and product characterization data collection and carry out data analysis. 5. 参与设计变更活动,确保设计变更过程符合法规要求。 Participate in design change activities and ensure that the design change process complies with regulatory requirements. 6. 与研发部门和生产部门合作,协助完成产品设计转换过程,并负责设计转换过程中的偏差处理,确保偏差被记录并合理处理。 work with R&D and manufacturing to assist in the product design changeover process and be responsible for handling deviations during the design changeover process, ensuring that deviations are documented and handled appropriately. 7. 主导产品风险管理工作,熟悉ISO14971、DFMEA、PFMEA,推进质量风险评估和风险控制措施的实施、监督实施过程。 Take the lead in product risk management, familiar with ISO14971, DFMEA, PFMEA, promote the implementation of quality risk assessment and risk control measures, and supervise the implementation process. 8. 设计和开发相关过程质量管理体系的培训工作。 Design and development related process quality management system training work. 9. 负责研发项目的质量文档和记录的管理工作,确保质量文档的完整性和规范性。Responsible for the management of quality documents and records of R&D projects to ensure the completeness and standardization of quality documents. 10. 负责指导、规范测试员的测试方法和测试技能,定期开展产品测试规范和安全操作培训。Responsible for guiding and training test methods and test skill, and carrying out regular training on product test specifications and safe operation. 11. 支持产品的设计验证、设计转换过程中的测试工作。 Support the test work of product design verification, design conversion process.
Qualifications: 1. 本科以上学历,机械或电子相关专业, 能熟练运用CAD、PRO/E、Solidworks、UG等软件。 Bachelor degree or above, majoring in mechanical or electronic related majors, skilled in the use of CAD, PRO/E, Solidworks, UG and other software. 2. 5年以上新产品导入(PE、ME)相关工作经验,熟悉产品DFMEA要求,熟悉结构及工装夹具防呆设计验证,了解模块化设计及测试自动化等概念,熟悉生产工艺规划设计(3P)。 more than 5 years of new product introduction (PE, ME) related work experience, familiar with product DFMEA requirements, familiar with the structure and fixtures and fixtures anti-dumbing design verification, understanding of modular design and test automation and other concepts, familiar with the production process planning and design (3P).
- 具有生产场地、生产设备、装配工艺流程规划、作业指导书编写等实际工作经验。 Have practical working experience in production site, production equipment, assembly process planning, work instruction writing. 4. 熟悉PFMEA及QCP工具;熟悉问题解决工具(鱼骨图、5why法、QC7大工具、8D等),对精益生产有一定的了解。 Familiar with PFMEA and QCP tools; familiar with problem solving tools (fishbone diagram, 5why method, QC7 tools, 8D, etc.), and have a certain understanding of lean production. 5. 有较强的沟通协调能力。
Strong communication and coordination skills. 6. 医疗器械行业从业者和熟悉ISO13485系统、APQP者优先。 Medical device industry practitioners and familiar with ISO13485 system, APQP is preferred.