长沙招聘

主要工作职责 Key Responsibilities: (概括关键职责、每项职责所要达成的结果/primary deliverables of roles)

1. 质量体系优化 QMS optimizing

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。

Per medical device regulations and firm real situation, optimizing QMS flow and related activities.

2. 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。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.

3. 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: (该职位任职者所需具备的成功要素/ Key success factors the job holder should have)

· 文化程度Education (学历/专业Degree/ Major):

本科学历，医学或制药等相关专业

Bachelor degree, medical or pharmaceutical related,

· 任职经验Working Experience:

3-5年质量管理体系经验

3-5 years experience in Quality System.

· 专业知识/技能Professional Knowledge/Skill :

1．清楚体外诊断试剂的生产流程

Clear production process of in-vitro diagnostics.

2．质量体系法规的相关知识，清楚美国FDA 21CFR Part 820，ISO标准，中国法规等。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. 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. 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.

2. 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.

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