Responsibilities职责:
1、与研发各部门合作,确保可制造性,质量,安全,周期时间等要求得到满足;
Partner with R&D to ensure Design for Manufacturab******** ********safety, cycle t******** etc. requirements are met;
2、定义生产流程,初始验收质量,周期时间,制造测试设备和文档的要求;
Define requirements for production process, initial acceptance ********cycle t******** manufacturing test e******** an********;
3、制定生产计划并执行以满足计划和里程碑目标;
Develop manufacture plans an******** to meet plan an******** targets;
4、确保在计划期间满足制造的所有QMS要求;
Ensure all QMS Re******** for manufactur******** are met during theprogram;
5、及时完成部门经理分配的其他工作。
Work timely on other tasks as assigne******** the Dept. Manager.
Requirements要求:
1、 工程或技术学士学位;
Bachelor's degree in Engineering or Technical discipline;
2、 3年以上在制造/工程环境方面的相关经验;
3+ years of relevant experience in a manufacturing/engineering inmedical environment;
3、 了解CFDA GMP流程和ISO 13485制造环境;
Knowledge of CFDA GMP processes an******** 13485 manufacturingenvironment;
4、 优秀的项目管理技能;
Excellent Project Management skills;
5、 能够识别/跟踪指标并推动持续改进。
Ability to identify/track metrics an******** continuous improvement.