Job Description Summary

Maintain and continuously improve Quality Management System (QMS) processes to ensure compliance with medical device regulations in applicable countries. Act as the key contact for internal and external audits, facilitating smooth audit execution and driving corrective and preventive actions (CAPA) for identified nonconformities.
Support new product design transfer and mass production transfer activities; participate in design reviews at all stages; review and approve DMR-related documentation for medical devices; evaluate Equipment Qualification and Process Validation (EQ/PV); and take responsibility for routine compliance checks on the production line.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter . Unlock your ambition, turn ideas into world changing realities , and join an organization where every voice makes a difference, and every difference builds a healthier
world.

维护和优化质量管理体系的流程，以确保体系流程满足相关国家的医疗器械的法规要求，并在内/外审核中做为审核对接人支持相关审核顺利开展，推动不符合项的纠正预防CAPA等相关工作。
支持新产品的设计转移活动和量产产品转移活动，参与各阶段设计评审，批准医疗器械的DMR相关文件，评审EQPV，负责产线日常的合规检查。
GE HealthCare 是全球领先的医疗技术和数字解决方案创新企业。我们的使命是在关键时刻改善人们的生活。释放你的抱负，将创意转化为改变世界的现实，加入一个让每个声音都被倾听、每一份影响都能共同构建更健康世界的组织。

Job Description

Roles & Responsibility:

    Review QMS related DMR files according to GEHC QMS procedure during design transfer and production transfer stage to ensure manufacturing related procedures, working instruction, SOP meet product design outputs. Including flowchart, SOP, Check sheet, process validation plan/ report, packing process validation plan/report, tools qualification plan/ reports, production training metrics.

    Analyze medical device regulation change and improve GEHC QMS procedure and local QMS procedure, ensure QMS meet intended country regulation (such as FDA Part820, NMPA regulation, MDR, ISO13485).
    Lead internal audit to ensure GEHC QMS effectiveness and sufficiency, take main contact window during external audit and NB inspection. Responsible for tracking and driving Corrective and Preventive Actions (CAPA); able to lead cross-functional teams in analyzing nonconformities, utilize quality tools to perform root cause analysis, and develop as well as review corrections, corrective actions, and preventive actions.
    Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
    Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
    在设计转移和生产转移阶段，根据 GEHC QMS 程序要求，审核与 QMS 相关的 DMR 文件，确保与制造相关的流程、作业指导书及 SOP 符合产品设计输出要求。内容包括工艺流程图、SOP、生产批记录、工艺验证计划/报告、包装工艺验证计划/报告、工装/设备确认计划/报告以及生产培训指标等。
    分析医疗器械法规变化，持续改进 GEHC QMS 程序及本地 QMS 程序，确保质量管理体系符合目标市场国家的法规要求（如 FDA 21 CFR Part 820、NMPA 法规、MDR、ISO 13485 等）。
    主导内部审核，确保 GEHC QMS 的有效性和充分性，并在外部审核及公告机构（NB）检查期间担任主要对接窗口。负责跟进纠正预防措施，能带领相关部门对不符合项进行分析，使用质量工具进行根本原因分析，制定和评审纠正，纠正措施和预防措施。
    运用对专业领域的深入知识及分析思维来执行相关政策与战略；同时具备相关岗位领域的基础知识。
    作为经验较少同事的支持资源；可主导低风险、资源需求较小的项目；能够清晰传达信息，并逐步提升引导团队在专业问题上达成共识的能力；传递绩效期望，并能够处理一定的敏感问题。

Qualification/Requirements:
    The position requires a minimum of 3 years of experience in quality compliance within the medical device industry. Educational qualifications should be equivalent to a bachelor’s degree obtained from an accredited higher education institution.
    该岗位要求在医疗器械领域具有3年及以上的质量合规工作经验。学力水平相当于从正规高等院校取得学士学位 

Desired Characteristics：
    Good verbal and written communication skills in English. Strong interpersonal and leadership abilities. Capable of working independently with strong problem-solving skills.
    Hands-on experience in establishing Quality Management Systems for active medical devices, with production experience in active medical devices. In-depth knowledge of regulations such as GMP and ISO 13485.
    Positive and proactive mindset with a strong team-oriented spirit.
    优秀的英语口头和书面沟通能力。优秀的人际关系和领导能力。能够独立工作。较强的解决问题能力。
    对有源医疗器械的体系搭建有相关工作经验，从事过有源医疗器械的生产工作，对GMP/ISO13485等法规有深入的了解。
    积极乐观，有团队合作精神。

Inclusive Diversity Paragraph：

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behavior Statement：

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.

Total Reward Statement:

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information