職責(zé)描述：
Responsibilities:
Design Control of quality function: 研發(fā)項(xiàng)目中的質(zhì)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.
確保設(shè)計(jì)輸入和設(shè)計(jì)輸出文件符合相關(guān)法規(guī)，設(shè)計(jì)歷史文件的完整性和追溯性
Support of design change request.
支持設(shè)計(jì)變更中的相關(guān)質(zhì)量活動
Verification and Validation: 驗(yàn)證與確認(rèn)
- Expert in verification and process validation procedures 熟悉驗(yàn)證與過程確認(rèn)的相關(guān)流程
- Provide quality approvals of plans, procedures, and reports for verification and validation activities 作為質(zhì)量人員起草，批準(zhǔn)生產(chǎn)過程確認(rèn)的相關(guān)方案和報(bào)告
Support risk assessment activities: FMEA, FTA.
參與風(fēng)險(xiǎn)分析活動，F(xiàn)MEA, 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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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.

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