Senior Quality Assurance Specialist

岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

This position is responsible for site quality assurance program implementation, including in-coming control, shipping temperature verification, inspection tour in warehouse, sampling check, etc. ensure inbound and outbound on time in full, logistics suppliers management, operation procedure and cost effective control improvement.
负责执行质量保证程序，包括：进货检验，现场巡检，运输温度确认，样品确认；进出库操作及时准确性保证，供应商管理、物流程序及成本控制优化等

主要职责 / MAIN ACCOUNTABILITIES

In-coming and outbound control / 进出货检验
a) Perform in-coming inspection, Verify the documentation from supplier along with shipment to make sure meet China MD regulation requirement / 进行进货检验， 确认产品随货同行单，确认对中国医疗器械法规的符合性；
b) Verify temperature when goods arrival, exchange with global on goods release or not / 确认产品到货温度，与总部沟通确认产品是否放行；
c) Evaluate damaged goods and make suggestion on usage decision / 评估受损产品，对产品处置给出建议；
d) Obtain Acceptance Certificate and given to 3PL supplier / 获取产品合格性证明，并交给第三方物流；
d) Track 3PL inbound and outbound operation ensure KPI and SOP fulfillment; finish relevant SAP handling and documentation /跟踪第三方进出库操作，确保操作满足KPI并符合流程要求；完成必要SAP操作及单据更新存档。

Printing Material Activities Inspection / 贴签活动检查 
a)  Onsite inspection on  labeling activities implementation at operation level /检查供应商贴标行为是否按照要求进行；
b)  Support 3PL to obtain missing info from internal cross department / 协助第三方物流从内部获取缺失的相关信息；
c)  Verify printing material from external supplier or 3PL to make sure meet BMX requirement and China MD requirement  / 确认自制或外购的印刷物料，确保相关法规的符合性；

Warehouse tour / 现场巡检
a)Follow regulation involvement and timely deliver related trainings to the warehouse operators  / 根据法规发展，及时给仓库员工进行培训；
b)Regular implement roving in warehouse to verify goods status and compliance level to regulation / 定期对仓库进行巡检，确保产品储存符合法规要求和梅里埃要求；
c)Timely deliver info. between BMX and 3PL / 及时协调传递梅里埃和第三方物流公司的相关需求；

Support Quality team for on-site inspection / 支持相关现场检查或审核；
Support team member on QMS related activities / 支持质量部其他成员相关工作。
Coordinate the supply chain and other internal parties communication with external 3PL to ensure logistics operation smooth / 协调供应链和其他内部团队与第三方的沟通确认物流相关运作的顺畅

Logistics supplier and cost management/物流供应商及相关成本管理
a)Warehouse and carrier operation process setup and modification/仓库及承运商等相关物流供应商相关操作流程设立与及时更新
b)Ensure operation and cost efficiency and effective by suppliers KPI tracking and review and continuous improvement/供应商绩效跟踪考核与持续改进确保高效的运作与成本

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

1. Education background: biological Engineering, Pharmaceutical related are preferred / 教育背景：生物工程，药学，检验学等相关专业优先
2. 1/2 years working experience as plus / 1-2年工作经验者优先
3. Good command of English in both written and oral / 英文熟练 
4. Good communication and interpersonal skills / 良好的沟通技能
5. Team work and take initiatives; self-discipline and work independently / 团队合作精神、主动工作、具有较强自律能力并能独立工作
6. Work under pressure / 抗压能力强