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1. 岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
1）项目：参与医疗器械仪器技术转移，并支持质量控制相关流程本地化以及产品在中国大陆地区的仪器产品注册。
Project: Participate in medical device instrument technical transfer, and support for QC procedure localization and instrument product registration in China mainland.
2）常规运营：商业化生产的质量控制检查和审核等支持性活动。
Routine Operation: QC inspection and audit etc. supporting activities for commercial manufacture.
3）履行维持有效的质量体系并确保产品质量的基本职责。
Perform essential duties that maintain an effective quality system and ensure product quality.
2. 主要职责 / MAIN ACCOUNTABILITIES
1）Safety, Health & Environment /安全，健康和安全
确保符合总部EHS方针、本地法规以及ISO14000的需求。
Ensure compliant to global EHS policy, local regulation and ISO 14000 requirements.
2）Quality and Regulation/质量和法规
确保遵守国家药品监督管理局相关法规、ISO 13485 标准以及其他适用行业规范，以支持完成公司目标。
Support the company’s goal of ensuring compliance with NMPA regulations, ISO 13485 standard and other industry codes applicable.
3）Project /项目
转移并本地化质量控制相关程序以适应中国当地的规范、法规，并符合产品技术要求和本地强制性标准。
Transfer and localize QC related procedures to adapt to China local codes or regulations, and meet product technical requirements and local mandatory standards.
支持供应商采购物料的评价和必要的样品试验。
Support the evaluation of supplier purchased materials and necessary sample testing.
确保按照既定规范和测试程序的要求对采购零件、材料、组件、软件和其他所需物品进行检查，包括外部供应商委托检测，以及最终在ERP系统中的放行
Make sure incoming parts, materials, components, software and other items as required are inspected per the requirement of established specification and testing procedure, including to entrust external supplier to commission testing, and final release in ERP system.
确保质量控制检测仪器和设备符合验证和/或校准的要求，以及日常维护工作以维持验证和/或校准状态。
Ensure meet requirements for qualification and/or calibration of QC testing instrument and equipment，and routine maintenance activities to maintain qualification and/or calibration status.
基于项目需求支持仪器的型式检验或其他验证/确认等工作。
Support instrument type testing or other qualification/verification activities per project required .
支持工厂、集团质量以及监管当局的良好生产规范和ISO 9001/ISO 13485质量体系等审核活动
Supports site, corporate and competent authority quality system audit activities of GMP and ISO 13485 etc.
必要的苏州工厂出差（每月10%左右）
Necessary business trips to Suzhou factory (about 10% per month)
4）Routine Operation/常规运营
不断优化QC相关程序以适应中国当地的规范或法规, 并符合产品技术要求和本地强制性标准。
Keep optimization QC related procedures to adapt to China local codes or regulations, , and meet product technical requirements and local mandatory standards.
确保按照既定规范和测试程序的要求对采购零件、材料、组件、软件和其他所需物品进行检查，包括外部供应商委托检测，以及最终在ERP系统中的放行。
Make sure incoming parts, materials, components, software and other items as required are inspected per the requirement of established specification and testing procedure, including to entrust external supplier to commission testing, and final release in ERP system.
确保质量控制检测仪器和设备符合验证和/或校准的要求，以及日常维护工作以维持验证和/或校准状态。
Ensure meet requirements for qualification and/or calibration of QC testing instrument and equipment，and routine maintenance activities to maintain qualification and/or calibration status.
基于需求支持仪器的定期验证/确认等工作。
Support instrument periodical qualification/verification activities per required .
支持工厂、集团质量以及监管当局的良好生产规范和ISO 9001/ISO 13485质量体系等审核活动。
Supports site, corporate and competent authority quality system audit activities of GMP and ISO 9001/ISO 13485 etc.
负责质量控制耗材的采购并确保其安全库存。
Responsible for the procurement of quality control consumables and ensuring their safety inventory
质量事件和变更控制等并作为质量控制专家给与评估，并执行分配的任务。
Be responsible for QC test for environment/PW monitoring and complete trend analysis in time.
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