Sr. Associate Specialist, Quality

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

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 820NMPA 法规MDRISO 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 bachelors 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 -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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.