上海招聘

  

Compliance, Test & Validation Engineer

Position Summary/职位概述:

  

Experienced to do products test and validation work in major scope as equipment and instruments, laboratory heating and temperature controlling equipment, fluid handling pumps and vacuum pumps, etc. Be familiar with different regulations and compliance requirements in related with above products and industries; Have proven records involved in UL/TUV/CE/ITL/ATEX test and certifications; Hands-on experience to operate QC analytical equipment and T&M instruments. Independently conduct a validation service or verification work with collaboration of the customers and third-party agency.

  

需要在产品测试和验证方面经验丰富，主要从事的行业包含设备仪器、实验室加热和温控设备、流体处理泵和真空泵，等等；熟悉多种法规和标准的要求以及认证流程，如UL、TUV、CE、ITL、ATEX的测试和认证；具有实际操作QC分析设备和测试测量设备的经验；能够独立主导客户方或第三方机构的测试或认证服务。

  

  

Key Responsibilities/主要职责:

  

1. Develop and maintain test plans, procedures and test cases, provide to internal and external customers, ensure the products to satisfy the defined requirements.

   开发并维护测试计划、流程和用例， 提供给内、外部客户，确保产品满足预定的要求；

2. Organize and perform tests in plant or project sites, record pass/fail status of the tests and identify problems, generated test reports.

   组织实施厂内和客户现场的测试工作，记录测试结果状态、识别问题并制作测试报告；

3. Analyze the failures found in testing and support the internal team to find the root cause of the issues.

   分析测试过程中发现的问题，并支持内部团队找出问题的根本原因；

4. Prepares problems tracking reports and follows up the corrective actions coordinating with the involved departments.

   准备问题跟踪报告, 并协调相关部门落实更正措施；

5. Provides recommendations for the resolutions regarding test and validation when new products are in development

   新产品开发时期，提出测试和验证问题的方案建议

6. Operate on own hands or coordinate the third-party test agency to conduct the compliance tests and finish certifications.

   自己独立操作试验仪器，或者协调第三方测试机构合作，完成符合性测试及认证。

7. Communicate and calibrate with customers, BDM, PM and Sourcing Engineers to provide recommendation of solutions regarding compliance tests.

   沟通与配合客户、市场部、项目经理以及供应商开发部门提供认证测试相关的建议方案

8. Cross functional working with internal team to drive quality initiative improvement on final test area.

   跨部门合作并与内部团队一起推动产品最终测试相关的质量改进活动。

                                  

1. Provide training courses to both internal teams and external channel partners about test and validation.

   给内部团队和外部渠道伙伴提供测试验证相关的培训；

   Minimum Requirements/Qualifications/最低要求与资格:

          

1. Bachelor of Electrical Engineering, Mechatronics or equivalent

   电子工程、电气或者机电一体化相关专业本科以上

2. Have at least 5 years working experience in laboratory equipment testing or related area

   具有5年以上实验仪器类产品的测试或相关领域的工作经验

3. Familiar with software testing process, basic testing method and criteria

   熟悉实验设备相关产品的测试流程，基本测试方法和标准；

4. Have experience in test requirement analysis and test design

   具备测试需求的分析能力和测试设计的能力；

5. Strong with compliance test procedure (e.g. CE, UL, TUV, ATEX, CCC, etc.), able to coordinate the certification independently.

   熟练掌握符合性测试的流程， 如 CE，UL， TUV，ATEX，CCC，等等， 能独立完成认证相关的协调工作

6. Better to be familiar with GxP requirements like GMP/GLP/GEP, good understanding to regulations from FDA, CFDA/NMPA, EMA, MHRA, ICH-8/9/10/14, WHO, ISPE, ASTM E2500, etc.

   熟悉GxP要求，如GMP、GLP、GEP，对FDA、CFDA/NMPA、EMA、MHRA、ICH-8/9/10/14、WHO、ISPE、ASTM E2500等标准有良好的理解***；

7. Capable to write documents like validation master plan, 3Q documents and detail reports is a plus.

   有能力编写验证总体计划、3Q文件和详细报告***；

8. Good language skills in both Chinese and English

   良好的中、英文语言能力

   Non-Negotiable Hiring Criteria/无协商聘用标准:

                                      

1. Must be able to travel within China or internationally on business trips when necessary.

   必须能接受必要的国际或者国内出差；

2. Must be able to function independently, be self-motivated and yet be part of a team.

   必须能够独立、自发地工作，同时能够与团队合作；

3. Must possess strong communication skills both verbal and written to communicate directly with customers and share technical information and provide documents.

   必须有较强的与客户进行口头和书面沟通的技巧，有分享技术信息和提供文件的能力；

4. Must possess strong organizational skills to meet deadlines and service customers in a timely manner.

   必须有较强的组织技巧，能在规定的时间内达成客户需求，及时提供所需的客户服务。

   Working Conditions/工作条件:

   Normal office environment, willing to travel when necessary

   正常办公环境，必要时能出差；

                          

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.

  

以上陈述仅仅是描述该职位所需人员的普通工作内容与要求， 但并不是所有的工作职责都已经详尽地列在这里。

  

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