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QA Engineer

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Location: Suzhou, China
Position Type: Fixed-Term
Job Function: Quality


  • 作为质量保证主题专家提供指导和专业知识

Serve as a quality assurance subject matter expert to provide guidance and expertise

  • 作为技术转移以及整个产品/系统生命周期中的质量观点的独立评审人。

Serve as a independent reviewer on account of quality viewpoint in regard to technology transfer and through the whole of product/system life cycle.

  • 基于风险评估和用户需求,识别并计划各种必要的验证活动。

Recognize and plan various essential validation activities based on risk assessment and user’s requirement.


  • 在项目提供质量专业知识,以符合当地医疗器械法规和相关标准。

Provide quality expertise in the project to compliance to local medical device regulations and relevance codes.

  • 参与并支持项目计划,质量计划和验证计划的开发,并按计划监管相应活动的展开。

Participate and support in development on project plan, quality plan and validation plan activities, and supervise corresponding activities according to the plans.

  • 作为质量代表和主席,根据法规和公司内部质量体系文件要求进行项目文件,异常记录,验证和确认文件等可交付文档的评审。

Serves as a member as a quality representative and chairperson, to review deliverables such as project files, validation and qualification documentations etc. against regulations and company internal quality management system procedures.

  • 在整个产品/系统生命周期内,支持跨职能部门进行产品、设备和过程风险管理。

Assist cross function on the product, equipment and process risk management along all the product/system life cycle.

  • 作为质量代表和主席,根据法规和公司内部质量体系文件要求进行质量事件、原因调查、纠正和预防措施、质量变更控制和工厂投诉调查的协调和评审。

Serves as a member as a quality representative and chairperson, to coordinate and review quality event, cause investigation, CAPA, quality change control and site level compliant investigation against regulations and company internal quality management system procedures.

  • 负责生产过程的质量监督,包含成品目视抽检及批记录的审核等,确保产品质量符合产品注册技术要求。

Responsible for the quality supervision of the production process, Including the visual inspection of finished products and batch records review etc. to ensure that the product quality meets the technical requirements as product registration.

  • 根据需要支持供应商或内部审核活动。

Supporting supplier and internal audit activities as necessary.

  • 履行由公司规程规定或由直属上级指派的其他任务。Other tasks as defined in related company procedure, or assigned by the direct supervisor.


  • 本科及以上学历,制药或医疗器械科学/工程或其他相关专业。至少5年以上医疗器械生产行业质量管理经验。

Bachelor’s degree or above, Pharmaceutical or medical device science/engineering or related majors. At least 5 years’ experience as quality management in medical device manufacture industries.

  • 熟悉GB/T 42061 (ISO 13485) 及其他质量管理体系相关的法规及标准,有内审员证书为佳。

Familiar with GB/T 42061 (ISO 13485) and other quality management system related regulations and standards, preferably with an internal auditor certificate.

  • 熟悉医疗器械良好生产规范,包括但不限于《医疗器械生产质量管理规范现场检查指导原则》、《医疗器械生产质量管理规范》及其相关附录。

Familiar with quality good manufacture practice, including but not limited to "Guiding Principles for On-site Inspection of Good Manufacturing Practice for Medical Devices", "Good Manufacturing Practice for Medical Devices" and their related appendices.

  • 良好的英语口语和写作能力。

Good English oral and written ability.

  • 熟悉CFR 21 Part 11和GAMP 5为佳。

Familiar with CFR 21 Part 11 and GAMP is as better.

  • 熟悉精益和六西格玛质量方法论为佳。

Familiar with Lean and six sigma quality methodology is as better.

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