Quality Engineer II job opportunity at Abbott.

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DateMore Than 30 Days Ago bot
Abbott Quality Engineer II
Experience: General
Pattern: full-time
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degreeBachelor's (B.A.)
loacation China - Jiaxing, China
loacation China - Jiaxin..........China

      JOB DESCRIPTION: 主要职责 Core Job Responsibilities -    作为法规合规专家参与公司的各种项目工作，协调QA、RA部门对各个项目的支持工作。 -    Participate in projects of plant or affiliate as regulatory compliance representative, coordinate QA or RA issues within quality department and reach out to regulatory department. -    准备外部申报/注册资料如生产许可证、CIQ证书、FSMP及IFM注册申报等，与外部机构办事人员联系申报事项。 -    Prepare dossier for external application/registration such as ML, CIQ, FSMP, etc. Communicate with external agency contactor for application issues. -     -    负责工厂法规方面SOP及文件的维护，及对工厂的法规培训工作 -    Responsible for plant regulatory SOP and documents maintenance, responsible for plant regulatory compliance training activities. -    跟踪中国法规发展趋势，组织跨部门团队进行差距分析，并制定行动计划。 -    Track newly issued or revised chines regulations, have gap assessment and coordinate actions with cross function team. -    参与支持质量体系的其他工作，如内审等。 -    Maintenance site integrity management system, participate and support quality system related work, for example, internal audit.  -    负责管理政府现场取样工作。 -    Responsible for managing government on-site sampling work. 职位职责/范围Position Accountability / Scope Indicate the reporting relationships, products, budgets, throughput, level and purpose of contacts (internal and external), or other scope measures that are key to this position. -    向法规合规主管汇报，协助婴幼儿配方乳粉、特殊医学用途配方食品及其他相关产品的法规事务。 -    Report to regulatory compliance supervisor, responsible for regulatory issue of IFM products, FSMP and other products in JX plant -    组织内部相关部门，准备向外部机构的申请或注册工作资料，并协助完成各项内审、外审活动。 -    Ensure compliance of plant operation and successful application/registration in external agency including FDA, MOH, CIQ, etc. 最低学历要求Minimum Education -    食品科学、食品工程、食品分析等相关专业，本科及以上学历。 -    Bachelor Degree and above in food science, food technology, food analysis or related subjects  最低经验/培训要求Minimum Experience / Training Required -    对GMP、食品安全法规、婴幼儿配方乳粉、特医食品及乳制品国标有较好了解。 -    Good practical knowledge of GMP, food safety regulation, GB compliance in infant formula food, FSMP and dairy food manufacturing -    对HACCP、诚信体系、ISO9001等体系管理知识有较好了解。 -    Have good knowledge in HACCP, Integrity Management System, ISO 9001 etc, system. -    对食品生产过程及工艺有较好了解。 -    Have good understanding of food manufacturing process. -    具备流利的英语口语及充足的书面沟通能力。 -    Fluent spoken English and sufficient written communication skills.         The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Operations Quality       DIVISION: ANSC Nutrition Supply Chain          LOCATION: China > Jiaxing : 681 Shengtang Road       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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