Job Summary:
New supplier qualification and re-qualification
供应商的首次认证和再认证
Response of the Supplier Quality Control and Quality Assurance
供应商的质量控制和质量保障
Maintenance the Quality System in respective area.
责任范围内的质量管理系统维护
Responsibilities:
1. Response for new supplier qualification 供应商的首次认证和再认证
a. Co-operate with source engineer in new supplier qualification
协助采购完成新供应商的认证
b. Perform the quality system audit, audit report submission and corrective action follow up 供应商质量审核,审核报告的编写和纠正措施的追踪
2. Supplier Quality control and assurance 供应商的质量控制和质量保证
a. Align the material specification based on the new material or project requirement with supplier. 按照项目要求向供方统一物料规范
b. Confirm the FAI sample quality, co-operate with relative department for the sample improvement 首样的确认,与其他部门合作进行首样改进
c. Supplier performance report summarization and trend analysis
供应商绩效的追踪并形成报告,进行趋势分析
d. Co-operate with procurement persons for regularly supplier survey
与采购人员合作完成供应商调查报告
e. Handling all the supplier relative raw material quality issue, SCAR and take part in MRB meeting.
负责处理原材料的供应商质量问题,供应商SCAR和参与物料评审会议等
f. Take part in QA-on-hold rack management
参与QA滞留产品的管理
g. Regularly supplier quality system audit and follow up.
定期的供应商质量审核和追踪
h. Supplier quality improvement.供应商质量改善
i. Work with supplier and technic team on failure analysis. Provide and quality support to supplier And push suppliers to take effective corrective actions
参与技术团队一起分析失效,向供应商提供质量支持并推动供应商有效实施纠正措施。
3. Quality system maintenance 质量系统的维护
a. Take part in quality system implementation, maintenance and improvement
参与质量系统的执行,维护和改进
b. Response for any findings corrective action from external and internal audits 负责内部和外部审核不符合项的纠正
4. Fulfill the other tasks assigned by the manager.
上级安排的其他任务
Requirements:
Bachelor degree or above with Good English skill both in written and oral.
机电一体化或者电子专业本科或以上学历,良好的英语读写能力
Proficient in electronic material, PCB, electromechanical drive (motor, motor, etc.) and SMT
熟悉电子器件、PCB、机电传动(电机、马达等)和SMT专业知识
At least 3 years relevant working experience in international company, any medical device manufacturing experience is preferred.
3年以上的外企相关工作经验,有医疗生产企业工作经验优先
Be familiar with ISO9001, ISO13485 and relative quality tools.
熟悉ISO9001, ISO13485和其他质量工具
Good communication and team work skill.
良好的沟通能力和团队合作能力
职能类别: 医疗器械生产/质量管理
联系方式
上班地址:科技城
公司信息
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