职位描述
职责描述:
Responsibilities:
Design Control of quality function: 研发项目中的质量控制
Ensure appropriate Design Inputs and Design Outputs in evidence for project and adequate documentation and traceability are provided in the Design History File.
确保设计输入和设计输出文件符合相关法规,设计历史文件的完整性和追溯性
Support of design change request.
支持设计变更中的相关质量活动
Verification and Validation: 验证与确认
- Expert in verification and process validation procedures 熟悉验证与过程确认的相关流程
- Provide quality approvals of plans, procedures, and reports for verification and validation activities 作为质量人员起草,批准生产过程确认的相关方案和报告
Support risk assessment activities: FMEA, FTA.
参与风险分析活动,FMEA, FTA.
Qualifications:
-Bachelor or above in engineering or scientific discipline
-Bilingual: English/Mandarin required
-Quality assertiveness and quality mindedness.
-Project management – support multiple projects simultaneously
->3 years as Design quality
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企业介绍
The Sol-Millennium Group is dedicated to Building a Healthier Tomorrow and helping people live in a healthier world. Our team members are committed to improve the safety and well-being of healthcare workers and their patients with the design and development of safety medical devices. Sol-Millennium Group is a Global Healthcare Company providing innovative products and value added services through product development, manufacturing and distribution targeting safe injections and disposal of medical devices. Our belief that the front line professionals are critical in the development process, we continually are in touch to share knowledge, ideas with concentration on the improved functionality of injection safety which is led by our experienced Research and Development team. The Sol-Millennium culture focuses on continuous improvement, technological innovation and customer service.
http://www.sol-m.com