1.岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
85 项目：参与医疗器械仪器技术转移，并支持质量保证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 QA procedure localization and instrument product registration in China mainland.
85 常规运营：商业化生产的质量事件处理、文件审核等支持性活动。
Routine Operation: Support activities such as quality event handling, procedure review etc. support activities for commercial production.
85 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
85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
85 转移并本地化质量保证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 QA related procedures to adapt to China local codes or regulations, and meet product technical requirements and local mandatory standards.
85 确保技术转移符合相关内部程序和法规。
Ensure that technical transfer are compliant with relevant internal procedure and regulations.
85 识别与制造过程相关的潜在风险，并建议适当的缓解措施，以有效地减低风险。
Identify potential risks associated with manufacturing processes and suggest appropriate mitigation measures to minimize those risks effectively.
85 确定并实施有效的过程控制系统，以支持产品的开发、确认和持续制造，以满足内部和外部要求，和产品最终在ERP系统中的放行。
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet internal and external requirements, and product final release in ERP system.
85 在识别、优先级排序、沟通和解决质量问题时应用健全、系统的问题解决方法。
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
85 基于项目需求和工业化部门一起完成验证和确认，以及其他确认和文档审核工作活动。
Work with industrialization engineer in the completion of verification and validation, or other qualification and document review activities per project required .
85 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.
85 与跨职能团队合作，提供质量相关程序、解决技术问题并为项目里程碑做出贡献。
Collaborate with cross-functional teams to provide quality related procedures, solve technical problems, and contribute to project milestones.
85 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
85 不断优化质量保证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.
85 协助规划、制定、审核、实施和维护质量保证目标和相关标准操作程序。
Assist in the planning, development, review, implementation, and maintenance of Quality Assurance Goals and Standard Operating Procedures.
85 根据工厂、公司和全球规程，作为质量专家参与并协调供应商纠正措施、变更控制、投诉、不合格、流程控制和纠正预防系统的实施。
Participate and coordinate as the Quality SME in the implementation of supplier corrective actions, change control, complaints, non-conformances, process controls, and CAPA systems in accordance with site, corporate and global procedures.
85 支持并报告相关质量指标趋势分析，以推荐改进和/或纠正措施的举措（如适用）。
Report trending analysis of relevant Quality metrics to recommend initiatives for improvement and/or corrective actions, as applicable.
85 支持统计数据分析并提出建议，以确保质量和符合标准。
Support statistical data analysis and make recommendations to ensure quality and compliance with standards.
85 基于需求支持定期的验证/确认活动。
Support periodical qualification/verification activities per required .
85 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.
职位要求：
85 本科及以上学历，机械，电子，生物工程、医学工程等医疗器械相关专业，需要有至少3年以上的有源医疗器械研发或生产企业相关工作经验。
Bachelor degree or above, major in active medical devices such as mechanics, electronics, bioengineering, medical engineering, etc. and necessary to have at least 2 years of relevant work experience in active medical device R&D or production companies.
85 语言技能：英语和中文听、说、读、写熟练，有欧美外资企业工作经验者优先。
Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese, applicants with working experience in European and American foreign-funded enterprises will be given priority.
85 能熟练操作Word和Excel等办公软件，熟悉SAP和Trackwise Digital系统者优先。
Proficient in operating office software such as Word and Excel, candidates familiar with SAP and TWD system will be given priority.
85 有良好的团队合作能力。
Good Interpersonal skill and team player.
85 熟悉ISO 19001, ISO 13485, ISO 14971, GMP等医疗器械及生物安全等相关的法规规范，有ISO13485内审员证书者优先。
Be familiar with relative medical device regulation and bio-security and other codes, such as ISO 19001, ISO 13485, ISO 14971 and GMP, candidates with ISO13485 internal auditor certificate will be given priority.