Quality Engineer

Job description

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. 主要工作职责 Main responsibilities: • 负责产品历史记录（批记录）整理和审查，确保产品历史记录的完整性、准确性及符合质量体系要求 To collect and review device history records (DHR/batch records) and ensure their integrity, accuracy, and compliance with quality requirements. • 负责产品的放行 Responsible for product release • 参与不符合品处理流程，重点负责影响成品质量的不符合评审，并参与已出工厂但未交付客户产品的质量滞留及后续处理 Involved in non-conformity review process • 参与产品过程确认和验证总计划的制定、评审及实施跟踪，确保相关活动符合质量体系和法规要求 Participate in the non-conformity handling process, with focus on review of non-conformities impacting finished products, and support quality hold and disposition activities for products released from factory but not yet delivered to customers. • 作为内审员参与质量体系内部审核和过程审核，编制审核报告，并跟踪审核过程中提出的发现项及相关改进措施的落实情况 Act as an internal auditor to participate in quality system and process audits, prepare audit reports, and follow up audit findings raised during audits and related improvement actions • 参与新产品的转移项目，负责转移产品项目的 QA 方面的相关活动 involved in new product transfer projects and responsible for QA relevant activities in project transfer project • 完成质量经理或主管临时交办事项 Complete temporary matters entrusted by Quality manager or QA supervisor 知识 / 技能 / 工作经验 Required Knowledge/Skills/Experience: • 本科及以上学历，机械、医疗器械或相关专业优先 Bachelor’s degree or above, preferably in Medical Device, Mechanical Engineering, or related majors. • 至少三年在制造业质量控制经验 , 具有医疗行业 GMP 工作经验者优先考虑。 Minimum 3 year quality control experience in manufacturing, with GMP experience in medical industry is preferable. • 具备基本英语沟通、阅读及书写能力 Basic English communication, reading, and writing skills are preferred. • 熟悉 ISO 13485 、 21 CFR 820 体系标准 ，《医疗器械生产质量管理规范》等法律法规 Familiar with ISO 13485, 21 CFR 820 system ， Chinese < Good Manufacturing practice of medical devices> • 熟悉质量工具及基本统计方法（ SPC 等） Familiar with quality tools and basic statistical techniques (e.g., SPC). About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.