QMS and Vigilance Team Leader

Q-CTRL • Full-time • 苏州市, CN • 1w ago

该职位来源于猎聘

Assist the Management Representative in organizing and coordinating internal audits, external audits and management reviews etc.. 协助管理者代表进行内审、外审和管理评审等任务的组织和协调。
Lead the site QMS and vigilance team and coordinate related quality management system activities. 领导工厂质量管理体系及医疗器械警戒团队，并协调相关质量管理体系活动。
Lead and develop the team and collaborate with cross-functional stakeholders to ensure alignment with and achievement of operational goals. 领导、发展团队，并与相关职能部门有效合作，以确保运营目标的完成；
Ensure the organization remains compliant with applicable QMS regulations and standards through maintaining QMS processes, supporting internal audits and coordinating external audits with notified bodies and/or local authorities. 通过维护质量管理体系流程、支持内部审核并协调公告机构和/或当地监管部门的外部审核，确保组织符合适用的质量管理体系法规和标准要求。
Manage medical device vigilance activities, including adverse event collection, assessment, reporting, record maintenance and follow-up actions according to applicable regulatory requirements. 负责医疗器械警戒相关工作，包括不良事件收集、评估、报告、记录维护及后续措施，并确保符合适用法规要求。
Identify environmental factors and develop and implement environmental improvement projects at work. Qualification and collection of chemicals suppliers and on-site audits 识别部门环境因素，在工作中制定和实施环保改进项目。
Continuous improvement of quality and environment integration system 对质量和环境整合体系进行持续的推进和改善工作。
Other tasks assigned by line manager. 直线经理安排的其他工作。 Education / 教育背景 Bachelor’s degree or above in Biomedical Engineering, Medical Device, Pharmacy, Life Science, Engineering or other quality/regulatory-related disciplines. 本科及以上学历，生物医学工程、医疗器械、药学、生命科学、工程类或其他质量/法规相关专业。 Experience /经验 Relevant work experience in quality management system or related quality/regulatory functional area in the medical device industry. 具备医疗器械行业质量管理体系或相关质量/法规职能领域工作经验。 Good knowledge of applicable medical device quality management system regulations and standards, including ISO 13485, China medical device GMP, EU MDR and applicable vigilance requirements; internal auditor qualification is preferred. 熟悉适用的医疗器械质量管理体系法规和标准，包括 ISO 13485、中国医疗器械 GMP、欧盟MDR ；具有内审员资格者优先。 Other skills /其他技能 Strong leadership skills and the ability to build and manage a capable team covering multiple quality functions. 具备较强的领导能力，能够建立和管理覆盖多项质量职能的专业团队。 Ability to exercise sound judgment in addressing production and quality management issues and to analyze and resolve non-routine product quality issues. 能够对生产和质量管理中的实际问题作出合理判断和处理，并分析和解决非常规产品质量问题。 Demonstrated people management capabilities, including effective employee selection, development and motivation. 具备良好的人员管理能力，包括有效的人员选拔、培养和激励。 Excellent interpersonal, communication and teamwork skills, with the ability to work effectively in cross-functional and cross-cultural teams. 具备优秀的人际交往、沟通和团队协作能力，能够在跨职能和跨文化团队中有效工作。 Good spoken and written English skills. 具备良好的英语口头和书面沟通能力。

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