QA Engineer II_Quality Operations job opportunity at Abbott.

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DatePosted 30+ Days Ago bot
Abbott QA Engineer II_Quality Operations
Experience: General
Pattern: full-time
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degreeGeneral
loacation China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area, China
loacation China > Hangzh..........China

      JOB DESCRIPTION: 主要职责/Key Responsibilities： 1. 负责产品实现各阶段（来料、生产过程、上市后客户反馈）的质量保证，确保生 产过程的稳定性和产品质量的可靠性。 2. 负责产品实现各阶段（来料、生产过程、上市后客户反馈）出现的不合格品和偏 差的处理，确保不合格品的追溯、标识隔离与处置。 3. 负责监督不合格品返工过程，确保返工过程有效控制。 4. 负责不符合事件和纠正预防措施系统的协调与跟踪，有效确保产品质量和质量体 系的持续改进。 5. 负责从客户退回产品的处理，确保退回产品的追溯、标识隔离与处置。 6. 负责生产过程物料报废管理，确保物料的可追溯性与有效处置。 7. 负责计划性偏差的协调与跟踪，有效控制短时的生产过程背离程序要求，以及恢 复到正常流程。 8. 负责批准产品放行。 9. 负责生产任务单和质量管理体系文件和记录的审核。 10. 负责供应商资质评审与首次质量体系审核，确保合格供应商的纳入。 11. 负责供应商定期绩效评价、监督和质量辅导，确保供应商状态的及时调整。 12. 负责供应商纠正预防措施的协调与跟踪，有效确保供应商物料质量和质量体系的 持续改进。 13. 负责供应商定期质量审核的策划与实施。 14. 负责供应商定期再评审工作，确保合格供应商的持续合格。 15. 参与基于客户投诉趋势分析触发的产品质量持续和流程的持续改进。 16. 参与客户反馈的及时响应，确保客户满意度的提升。 17. 负责产品召回和现场纠正措施的评估、处理与实施。 18. 参与产品和过程变更评审工作，确保变更风险得到有效控制。 19. 参与公司质量体系的内审工作和迎审工作。 20. 负责参与或主导公司内的项目策划与实施。 21. 负责质量数据的统计、分析和处置。 22. 完成上级临时交代的任务。 任职资格/Job Requirements： 1. 资格证书/Certificate： 有质量工程师或质量体系内审员等相关质量专业相关证书优先 2. 外语技能/Foreign Language Skills： 英语听、说、读、写熟练，大学英语四级及以上优先 3. 计算机软件技能Software Skills： 熟练掌握办公软件（word，excel，PPT 等软件）的操作技能 4. 工作经验或专业背景/Work Experience or Professional Background： 3 年以上药品、食品、医疗器械质量管理工作经验优先 5. 教育背景/Education Background： 大学本科及以上（生物、化工、医药相关专业优先） 6. 其它要求/Others： 思路清晰、较强的语言表达能力、沟通、协调能力       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: ID Infectious Disease          LOCATION: China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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