职位介绍

职位摘要SUMMARY
本职位主要负责公司设施的质量管理体系。协调和执行ISO 13485质量体系的计划。为所有员工提供质量管理方面的培训。参与并支持符合质量管理体系要求的活动。
This position is primary responsible for the quality management system of company facility. Coordinate and execute plans to maintain an ISO 13485 quality system. Provide training to all employees on quality management practices. Participate and support activities involving compliance with Quality Management System requirements.
工作职责ESSENTIAL DUTIES AND RESPONSIBILITIES
1. 负责确保公司质量管理体系的完整性符合ISO 13485, FDA 21CFR Part 820，法规要求。
Responsible in ensuring the integrity of the company's Quality Management System in compliance to ISO 13485, FDA 21CFR Part 820, Regulatory requirements.
2. 负责监督质量管理体系(QMS)在公司的有效实施。
Responsible in overseeing effective implementation of Quality Management System (QMS) throughout the company.
3. 负责审查和编写程序和流程，以支持质量管理体系的发展，以满足法规和业务需求。
Responsible in reviewing and writing procedures and processes to support QMS development to meet regulatory and business requirement.
4. 负责组织公司年度内审和内部过程审核，包括审核前策划、审核执行与评审、审核后跟踪。
Responsible in organizing the company's annual internal audit and internal process audit, include pre-audit planning, audit execution and evaluation and post-audit follow-up.
5. 负责组织客户审核和第三方审核的准备工作，协调和跟进提出的不符合项。
Responsible in organizing customer audit and 3rd party audit preparation, coordination and follow up the nonconformities raised.
6. 负责管理纠正措施/预防措施(CAPA)以达到KPI目标
Responsible in managing Corrective Actions/Preventative Actions (CAPA) to meet KPI target
7. 负责为管理评审会议准备审核和CAPA数据，并提交管理者代表。
Responsible in preparation of Audit and CAPA data for Management Review meeting, submitted to the management representative.
8. 为所有员工提供质量管理方面的培训
Provide training to all employees on quality management practices
9. 领导团队并为团队成员制定发展计划
Lead small group of team and create development plan for team members
10. 完成上级交办的其他工作
Other tasks assigned by superior
职位要求QUALIFICATIONS
1. 大学学位
College Degree
2. 至少4年以上质量体系实施工作经验
At least 4 years working experience in quality system implementation
3. 拥有丰富的客户审核经验，平均每年8次
Rich experience on hosting customer audits, average 8 customer audits a year
4. 拥有ISO13485内审员资格
Own ISO13485 Internal auditor qualification
5. 熟悉FDA和CFDA法规要求
Familiar with FDA & CFDA regulation requirements
6. 良好的英语听说读写能力
Good capability of written and spoken English
7. 团队管理领导经验。
5158 4841-|171 3430 5782 908. Experience of team management leadership.