无锡招聘

职位描述：
Requirements: 有医疗器械相关工作经验
Critical Experience and Skills
Chemistry, electronic, mechanical or relevant major, bachelor degree or above.
Good communication and influencing/negotiation skills with internal teams, clients, and the suppliers.
Minimum 5 years working experience in medical device industry and validation works.
Have been in charge of validation project, for example: computerized software validation (CSV), RO water system, and document management.
Profound understanding of medical device cGMP, 21 CFR 820, ISO 13485 and related standards .
Familiar with PCBA assembly and testing process, equipment and cleanroom e***ironment
Fluent in both oral and written English is a must
Excellent writing skills are preferred
Have medical device experience

Job Responsibility:
responsible for:
Management and organization of company’s validation master plan (VMP), validation documents and validation activities. Ensure all the relevant quality systems are continuously within the validation status and complying with the internal quality system and external regulatory and standard requirements.
In charge of the management of company’s validation system and the execution of VMP, including but is not limited to:
Software validation, packaging validation, cleanroom validation, final function testing and testing jig qualification
In charge of the validation management of company’s other cGMP project.
In charge of organizing the company’s annual validation and revalidation works.
In charge of all the relevant validation document management.
In charge of reviewing and/or draft of validation protocol, validation report, records and so on.
In charge of the validation training.
Fulfill and finish the workload allocated by up level manager.
Control or archive the validation protocols and reports.

Organizational Authorization
According to valid version of Company Handbook 举报 分享

    卡塞尔是一家面向全球市场提供合约制造的瑞典公司，公司业务包括为客户提供生产及成品运输服务。卡塞尔中国无锡公司自2006年3月建成投产，是一家现代化总装厂。在过去的实践中公司凭借完善的生产流程，充分证明了我们可以在斯堪的纳维亚与中国之间进行产品的制造与运输。公司现今的产品包括医疗设备、空气过滤器、工业吸尘器及广播通信设备等。卡塞尔无锡工厂占地8500平方米，专注于采购、生产和产品开发。现今公司营业额约为一千亿瑞典克朗，大约110名员工。
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