岗位职责Job Responsibility：
1. 质量管理体系建设/Maintenance of QMS：
1) 维护质量管理体系的有效运行。Maintain the effective operation of QMS.
2) 组织质量管理体系的教育培训工作。Organize and perform QMS training to staffs.
3) 监督并指导各部门落实企业的质量管理体系要求。Monitor and coach departments to implement QMS requirements.
4) 定期组织召开管理评审会议，报告实施质量管理体系的业绩。Organize and prepare management review meeting as planed intervals, report QMS running performance.
5) 收集各方面的建议，组织实施质量管理体系改进。Collect improvement suggestion and seek for QMS improvement.
2. 组织质量体系的审核与认证/Organization of QMS audit and certification:
1) 组织编制质量体系的年度内审计划。Prepare internal audit plan.
2) 全面负责质量管理体系内部审核工作及整改活动。Overall responsible for QMS audit and follow up reaction activities.
3) 主导二方和三方质量体系的审核认证工作，包含审核安排、审核结果跟进关闭等。Lead the customer audit and certification of three-party for quality system, including the audit arrangement, audit results follow up till to close.
4) 负责内部CAPA启动和调查处理工作。Responsible for internal CAPA initiation and investigation.
3. 组织协调完成产品PPAP要求资料和产品质量标准的评审。Organize and coordinate to complete the PPAP requirements and product quality standard review.
4. 参与部门EHS活动及公司EHS活动。Participate in departmental EHS activities and company EHS activities.
5. 上级领导安排的其他事宜。Other jobs arranged by manager.

岗位要求Requirements：
1.大学本科及以上学历。Bachelor degree or above.
2.熟悉ISO13485、GMP等质量管理体系要求。Good knowledge of ISO 13485\GMP standard.
3.具有二方或三方审核应对经验，如药监局、体系认证公司、客户审核等。Experience of two or three party audit response.
4.熟悉质量管理工具，如FMEA、MSA、CP等。Familiar with quality management tools ,FMEA、MSA、CP etc.
5.具有较强的分析和解决问题的技能。Strong analytical and problem solving skill.
6.具有良好的英语书写和沟通能力。Good in English verbal and written skills.
7.沟通能力强，良好的人际交往能力，责任心强、诚信、愿意学习。 Good communication and interpersonal skill, responsible, honest, and willing to learn.
8.有ISO13485内审员证或医疗包装行业经验优先。ISO13485 internal auditor certificate or xperience in medical device is preferred.