1. Conduct the quality process/system audits include oversea suppliers according with ISO 13485/9001&US QSR820 and our company requirements. Written the audit report and follow up the audit CAPA with the suppliers. Make sure the audit findings are closed during a period.
根据ISO 13485/9001, US QSR820以及公司的要求，进行包括海外供应商在内的质量过程/体系审核，并跟踪供应商的CAPA改进。确保审核发现项在规定时间内结束。
2.Teamwork with sourcing and product category department to evaluate the potential suppliers, make an evaluation for if it can be added in qualify supplier list. Find and announce the risk through audit findings. Evaluate and reduce our risk through audit findings and effective corrective action systems.
与采购和产品技术部门合作评估潜在新供应商，评估供应商是否可以加入合格供方名单。通过审核发现风险并且内部告知其他团队存在的风险。评估风险并通过有效的纠正措施系统降低风险。
3. Monitor and evaluate suppliers’ production, identify the potential risk and verify the effectiveness of each action after routine check include audit and inspection. Evaluate supplier's quality assurance level regularly.
监控并且评估供应商的生产，识别潜在风险，并通过例行检查，包括审核和检查，验证每项措施的有效性。定期评价供应商的质量保证水平。
4. Perform the pre-shipment inspection for the new developed products and regular inspection. Provide and follow up inspection CAPA if there have nonconformity during the inspection. Do the reinspection and monitor the rework if the order was rejected. Through inspection, familiar with the product quality requirements, give the inner feedback of upgrade if have.
对新开发的产品进行发货前检验和定期检验。如果在检验过程中有不符合，提供并跟踪检验CAPA。如果订单被拒绝，需要进行复验并监督返工情况。通过检验，熟悉产品的质量要求的特性，如果发现有升级产品要求的地方，反馈到公司内部。
5. Participate in new product/project development, update/review new product specification. Based on knowledge of the product, evaluate if the items in the specification are sufficient and reasonable, if it meet the requirements of the regulatory standards.
参与新产品/项目的开发，更新/复核新产品的规格书。根据对产品的知识，评估规格书的项目是否充分合理，是否能够满足法规标准的要求。
6. Handle investigation of customer complaints and ensures implementation of CAPA to prevent re-occurrence. Analysis the resolution of complex quality issues be means of root cause(s) identification. Focuses and guides the quality continual improvement efforts to attain total customer satisfaction and regulatory compliance.
处理客户投诉的调查，确保CAPA的有效实施以防止投诉再次发生。识别根本原因，分析制订一些复杂质量问题的解决方法。关注和指导质量持续改进工作，以达到客户满意度和法规合规性。
7.Ensures compliance of project activities to appropriate, latest regulations and standards (FDA, CFDA, ISO, EN). And establish and optimize the internal relevant procedure according to regulations and standards.
确保新项目新产品活动符合适用的最新的法规和标准(FDA, CFDA, ISO, EN)。并根据规定和标准建立和优化内部相关流程。
8.Supports the improvement of the effectiveness of the quality system including inspection systems, procedures and products datasheet, testing, customer complaints, and training.
支持质量体系有效性的改进，包括检验体系、程序和产品数据表、测试、客户投诉和培训。
Qualifications
1.Over 5 years’ experience in quality job, over 3 years’ experience of SQE or quality auditor or QMS and over 3 years’ experience in medical industrial.
2.Good Knowledge of quality standards such as ISO 13485, QSR820, ISO 11135, MDR.
3.Good at English (Written) and fluent oral is preferred.
4. Knowledge with Quality Management tools such as FEMA, SPC, Control Plan, and 8D tools is preferred.
5.Be able to business trip on China and Asia.