职位目标 Job Purpose：

1.协助质量体系负责人确保公司的生产活动符合相关质量管理体系法规及规范的要求。 Assist QMS head to assure firm manufacturing activities are in compliance with all relevant quality management system guidelines and regulations.

2.对于负责人分配的项目提供专业的支持，确保时刻符合质量管理系统的要求，并且质量系统的输出必须符合应用流程、项目和法规的需要。 Provide or facilitate the provision of expertise to QMS Compliance head assigned projects ensuring that compliance to the Quality Management System requirements is maintained at all times and Quality System outputs meet the needs of the applicable procedure, project, standards and regulations requirement.

主要工作职责 Key Responsibilities:

1．文件控制Document control 对公司各级质量体系文件进行管理，确保文件的编制、评审、批准、发布、发放、使用、更改、作废、保存和检索符合规定的要求。 Control over all documents required by the quality management system to ensure the generation, review, approval, issue, distribution, use, update, obsolete, storage and retrieval of documents meet the specified requirements.

协助起草和更新各级质量体系文件。协助各部门进行产品转移项目中相关产品文件的转移。

Assist in draft and update the quality management system procedures. Cooperate with each dept. to transfer the product file for each product transfer project.

根据客户要求或产品注册等需要，及时提供产品相关文件。Prepare relevant documents as per customer/ product registration required.

2．变更控制Change control 协助对变更进行控制，确保所有可能影响产品质量的更改，包括所有与产品生产相关的原材料、生产流程、设备、仪器、程序、标准、测试方法等的变更都经过相应评估和验证和记录，符合现有的流程和相关法规要求。 Ensure all the changes that have impact with the product quality including all product related materials, manufacturing process, equipment, instrument, procedures, specifications, methods, etc. are reviewed, assessed, evaluated, validated and documented according to the current procedure and comply with relevant regulations.

3. 质量体系优化及质量培训 QMS optimizing and Quality training 按公司培训计划对员工进行质量培训，不断提高员工的质量意识。依据法规要求和公司实际情况，优化质量体系流程或相关活动。 Responsible for employee quality training per company training schedule, continually improve the employee’s quality awareness. Per medical device regulations and firm real situation, optimizing QMS flow and related activities.

4. 质量监督/审核Quality monitoring / Quality audit 对与产品质量相关的活动进行监督。计划、参与及协调内部与外部审核。确保所有与内外部审核相关的纠正与预防措施被及时地、有效地完成。 Monitoring the daily manufacturing actives. Plan, participate and co-ordinate the internal and external audit programs. Ensure the implementation and follow up all the relevant corrective and preventive actions is taken timely and properly. 5. 其他Other 积极配合或执行部门/团队分配的其他工作任务。 Actively cooperate or implement other related work task arranged by dept. or team.

任职条件Qualifications:

文化程度Education (学历/专业Degree/ Major):

本科或以上学历，医学或制药等相关专业 Bachelor degree or above, medical or pharmaceutical related, ·

任职经验Working Experience:

3-5年质量管理系统管理经验 3-5 years experience in Quality System Management. ·

专业知识/技能Professional Knowledge/Skill :

1．熟悉体外诊断试剂的生产流程 Familiar with the production process of in-vitro diagnostics.

2．质量体系法规的相关知识，熟悉美国FDA 21CFR Part 820，ISO标准，中国、欧盟法规、加拿大、韩国、日本医疗器械法规等。在检查过程中能发现质量问题/偏差。 Working knowledge of Quality system, Familiar with US FDA 21CFR Part 820, ISO Standards, China regulations, EU Directives, Canada, Korea and Japan medical device regulations. Ability to identify quality issues/discrepancies in process supervision.

3．获得内审证书者优先考虑Internal Auditor Certificate preferred. ·

计算机及外语水平Computer & Language Skill:

1. 良好的英语口语和书写能力。 Good English skills both spoken and written.

2. 熟练使用电脑和办公自动化。 Fluent in using PC including Office Software. ·

能力要求Competency:

1. 拥有较强的文件管理知识。 Strong knowledge of documentation management systems.

2. 较强的流程管理意识，能够编写清晰、简明的程序和相关文件。 Strong process orientation, ability to develop clear and concise procedures and related documentation.

3. 能够培训员工执行法规和SOP的要求 Ability to train staff on following regulations and SOPs related to quality.

4. 良好的人际交往能力，团队合作精神 Good interpersonal skills, ability to communicate with all levels in the company. Good team work spirits.

上班地址：上海浦东李冰路151号7号楼