岗位责任l 制定和维护整个公司质量体系，保证遵守iso13485，fda的qsr，加拿大的cmdcas的规范.2 教育，培训，及给员工提供意见，以确保质量和监管要求。进行市场宣传材料的审查。审计业务单位保证合规性和一致性，跟踪和解决观察到的可能导致不合规，或给用户的带来安全风险的趋势。审查，批准和保持系统记录所需的所有文件。3 规划，制定和管理公司内部流程来监测，预测和调节研发和生产过程。使用适当的审计，测试和统计过程控制策略，使所有产品符合质量，安全性和有效性的要求。验证对可能影响质量的设备，工艺，系统和设施的变化。维护对研发和生产中所有设备，测量仪器定期校准工作。4 管理和产品相关的认证事务，以确保产品在目标市场上推出前完全符合当地法规。审查产品开发过程来保证设计阶段就考虑到法规要求。5 进行内部审计程序，以确保产品符合监管机构的规定。制定质量方案评估，鉴定和审核供应商，以减少供应商来料质量问题。6 代表公司进行认证机构如tuv公司或fda机构对公司的审计。7 建立产品生命周期管理从刚开始产品概念到产品终结。8 用技术，分析和管理的技能来评估和解决产品和工艺问题。管理关于产品质量的投诉，带领调查，进行趋势分析和采取纠正措施。job responsibilitiesl develops and maintains quality policy through the organization compliant with iso 13485, fda’s qsr, canada’ cmdcas.l educate, train, & advise company professionals to ensure compliance with quality and regulatory requirements.performmarket promotional materials review。audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety. review, approve and maintain all documentation required for system record.l plan, develop and manage program that monitor, predict and regulate the design, manufacturing process using appropriate auditing, testing and statistical process control strategies so that all products meets requirement for quality, safety and efficacy.validate new equipment, processes, systems, and facility changes that impact quality.maintain calibration program for all equipment, measuring devices and plant support system in r&d and manufacturing.l manage regulatory affairs related to the product to ensure full compliance with local regulation before product is introduced in the targeted market. review product development process to assure regulatory requirement is met during design stage.l conduct self-audit program internally to ensure compliance with regulatory agency requirement.develop quality program to evaluate, qualify and audit suppliers to reduce quality issues for incoming material.l represent the company for auditing of certification body and agencies such as tuv or fda.l establish procedure and practice to conduct product lifecycle management from initial concept stage to end of life.l evaluate and solve product and process problems by providing technical, analytical and managerial skills.manage product technical complaints, lead investigations, conduct trend analysis, and drive corrective actions.背景要求本科以上学历，受过医疗器械、产品知识等方面的培训；具备五年以上用医疗器械企业质量体系管理的经验。具备三年以上用医疗器械注册、报批的成功经验, 以及相关事故处理报告, 产品召回经验。熟悉iso13485，国家医疗器械产品注册(sfda, fda, mdd)方面的法律、法规，安全要求。了解(aami, iec, ul)各项标准，向国家和药监部门注册申报的流程和三类医疗器械注册规定。对产品研发流程和生产流程具备很好的了解具有良好的英文听说读写能力；能翻译外文资料；善于沟通与合作，富有团队精神。有很强的与各部门的联系及协作的经验。能够承受较大的工作压力，具备应急事件独立处理分析能力qualifications/requirements bachelor’s degree or higher in a technical discipline with good training in medical equipment products. minimum of 5 yearsexperiences in quality system management.minimum of 3 years in managing regulatory affairs of medical device.excellent knowledge of iso13485 system requirement，sfda and fda regulation.understanding of aami, iec, ul standard, fda, sfda application procedure.understand product development process and manufacturing process of medical devices.good with english in speaking, writing and reading perspectives. ability to translate document in english.excellent verbal and written communication and presentation skills, team player, coordinate efforts across departments. work under pressure. the ability to cope with urgency issues independently.