Sr. Quality System Specialist

Description/职位描述:
Implement, maintain and improve JJMSZ campus Quality Management System;
实施，维护并改进强生（苏州）医疗器材有限公司的质量体系；
Coordinate the implementation of QMS in each franchise to ensure all applicable standards and regulatory requirements are fulfilled;
协调质量体系在各品牌公司的运行以保证符合所有使用的标准和法规要求；
Support Compliance team for data trending analysis, audit management, metric reporting and etc.
支持合规团队进行数据趋势分析，审核管理，及指标报告等。
KEY RESPONSIBILITIES/TASKS (indicate estimated % of time spent where possible)/ 主要职责/任务(以时间的百分比表示)
1. 89% - Campus Quality 产业园质量
2. 10% - Franchise Quality 品牌公司质量
3. 1% - other Function 其它职能

Qualifications/任职要求:
ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标
Perform the principal duties of the Senior Quality System Specialist position/执行高级质量体系专员的主要职责:
o Support the QMS team to develop, implement, maintain and improve the quality system of the sites in accordance with Worldwide 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 Participate in the development of a fully integrated Quality System of the sites/参与开发工厂整合的质量体系
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 Serves as EtQ administrator (NC, CAPA and Audit) for the site and responsible for all tasks associated in accordance with all applicable Worldwide Quality requirements/担当工厂EtQ系统管理员(不合格, 纠正和预防措施和审核)并按适用的全球质量要求负责相关任务
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/Audit as required/按要求跟踪不合格, 纠正和预防措施和审核相关措施的执行。