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5-7年经验 -
本科 -
招1人 -
02-05 发布
职位描述
Key Areas of Responsibility: Lead the process related problem investigation to reduce the compliance risk. Lead the product quality related problem investigation to improve the product quality.Cooperate with cross functions with the SME and Process owners to run problem solving project timely.Facilitate the CAPA team to use right quality tools and follow right processes to manage the investigation process. Organize the CAPA review meetings to monitor the CAPA phases and escalate any potential risk if have. Cooperate with CAPA managers or other stakeholders to support the CAPA investigation and get tasks done timely. Document the CAPA investigation and organize the necessary review and approval meeting with team. Ensure the investigation are effective to reduce the risk and avoid the re- occurrence. Host the internal and external audit for CAPA section with CAPA owner supporting. Manage the CAPA tool well such as AMT and Trackwise. Team work with ULT BG CAPA team to do peer review and learn each other. Job Requirement & Skills:Qualification & Education: Bachelor degree+ Experience: >5 years of experience in quality management field and >3 years in CAPA engineering>5 years of experience in Medical device manufacturing Skills & Knowledge: Professional knowledge in equipment medical device industryBe family with quality tool of problem solving.Be familiar with FDA GMP & ISO 13485 requirements.Has experience of CAPA implementation. Personal Skills/ Attributes: Good team work spirit and communication skillsGood skill of project management. Very good English skillGood quality engineering skill. 职能类别： 医疗器械生产/质量管理 关键字： 质量工程师, quality engineer, 纠正与预防
联系方式
龙东大道3000号
公司信息
For over 10 years, Philips Ultrasound (Shanghai) Co. Ltd., has been a leading company in design, develop and manufacture medical ultrasound transducer for variety of applications. The company has become member of Philips Healthcare since 2010 and continues actively to provide high quality, high performance products to medical ultrasound customers.
