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Sr. Quality System Specialist

Auris Health

Auris Health

Quality Assurance
Suzhou, Jiangsu, China
Posted on Tuesday, September 12, 2023
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Description

o Support the QMS team to develop, implement, maintain and improve the quality system of the sites in accordance with global Quality strategy, / 根据全球质量策略支持质量管理体系团队开发,执行,维护并改进工厂的质量体系
o Maintain campus shared procedures/ 维护产业园共享流程文件
o Develop and provide related trainings to employees based on applicable regulatory requirements. / 基于适用的法规要求,开发并向员工提供相关的培训
o Serve as coordinator for the site DePuy Synthes post-delivery quality control activities, such as complaint investigation, China Adverse Event Monitoring and Re-evaluation Activities and Field Action, etc. /作为工厂DePuy Synthes 后市场质量控制活动的协调员,例如投诉调查,中国不良事件监测和再评价活动以及现场措施等;
o Primary contact of China Adverse Event Monitoring/作为中国不良事件监测的主要联络人;

o Work with Commercial Quality, Regulatory Affairs and Strategic Medical Affairs, etc in JJMS, local Regulatory Affairs and R&D, etc to ensure the reporting to Health Authority are completed in time/ 与强生(上海)医疗器材有限公司的业务质量,法规和战略医学事务等,本地法规和研发等部门合作确保向及时卫生监管当局的汇报;
o Coordinate Re-evaluation and Periodical Risk Evaluation and ensure the timely report to Health Authority according to regulation requirements. / 根据法规要求协调再评价及定期风险评价,并确 保及时向卫生监管当局汇报;
o Maintain ICQAs according to related procedures/根据相关流程维护内部公司质量协议
o Maintain and report appropriate Quality business measurements consistent with the Quality and Compliance dashboards to continually monitor the performance and roll up to Quality Progress Report and Quality System Management Review/维护并报告与质量合规报表相一致的适当的质量
业务量测指标以持续监控绩效,并汇总至质量进度报告和质量体系管理评审。
o Follow up with individuals for the implementation of actions related to NC/CAPA as required/按要求跟踪不合格, 纠正和预防措施相关措施的执行。
o Facilitate CAPA Review Board and provide training to promote the CAPA awareness within the organization/ 协调纠正和预防措施评审委员会的评审和提供培训以促进组织内的纠正和预防措施的意识。
o Prepare Quality Progress Report and Management Review meeting, and identify related actions with the review team and follow up with individuals to close all actions/ 准备质量进度报告和管理评审会议,和评审团队一起识别相关措施,并和措施相关负责人跟进所有措施的关闭。
o In connection with other departments in and outside JJMSZ to guarantee quality and compliance to support all business objectives/ 和强生(苏州)医疗器材有限公司内部和外部联系以保证支持所有业务目标的质量和合规。
o Perform routine data trending analysis when necessary. Identify opportunities to improve Quality, present recommendation and coordinate implementation as applicable/ 必要时执行定期的数据分析。识别质量改进机会,若适用提出建议和协调实施。
o Support all quality inspections (e.g. NMPA, US FDA, Notified Body, JJRC, etc…)/ 支持所有质量审核(如:国家药品监督管理局,美国食品药品监督管理局,公告机构,强生法规合规部门等)。
o Perform all job duties in full accordance with/ 完全按照以下要求执行所有职务:
o The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information/ 强生政策要求,资产保护,维护密码的机密性,保护关键业务信息。
o All J&J policies and local regulations/ 所有强生政策和本地法规。
o The policies of the Health Care and Environmental programs/ 卫生保健和环境项目的政策。
o The code of conduct policies/ 行为准则政策。
o Other assignments from supervisor/ 主管的其它指任。

Qualifications

▪ Familiar with Medical Device Regulatory requirement for QMS 熟悉医疗器械法规对质量体系的要求
▪ Fluent in using MS Outlook, Excel, PPT, etc 熟练使用Outlook, Excel, PPT 等办公软件

▪ Fluent Oral/Written English/英语说写流利