【北京 QA Specialist招聘】-猎头顾问北京招聘信息-猎聘

潘女士 2天前在线已认证

顾问 · 北京外企人力资源服务有限公司

简历处理快

聊一聊

职位介绍: Job Responsibilities Be responsible for the application, NMPA registration and compliance implementation of Class II and Class III medical device business qualifications, and coordinate regulatory inspections and flight inspections. Based on the mature overseas quality system, complete the localized establishment, document revision and daily operation of ISO13485 and medical device GMP systems. Establish a quality control system for OEM factories, including supplier qualification, on-site audits, deviation handling, CAPA closure and production process quality supervision. Conduct label review, compliant labeling, batch traceability, non-conforming product management, and adverse event reporting and handling for imported products. Cooperate with business departments to identify compliance pain points, provide QA solutions, and balance overseas standards with domestic business implementation. Independently communicate with the US headquarters quality team, including translation, interpretation, synchronization of English quality system documents and daily English communication. Job Requirements Bachelor’s degree or above in Medical Devices, Biology, Pharmacy, Laboratory Medicine, Pharmaceutical Engineering or other related majors, meeting NMPA qualification requirements for quality principals of Class II and Class III medical devices. At least 5 years of working experience in medical device QA, including more than 3 years of practical experience in Class II/III business licenses and GMP production systems, with experience in OEM system establishment and QMS construction. Fluent English as a working language, able to independently communicate with overseas teams and attend English interviews. Practical ability in qualification application, system implementation and factory audits; Background in assisted reproductive/IVF medical devices or multinational companies is highly preferred.

其他信息: 语言要求：不限; 行业要求：制药

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