QA Engineer at GE HealthCare

Beijing, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

12 Mar, 26

Salary

0.0

Posted On

12 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GMP, ISO13485, QSR, Risk Management, Data Analysis, Problem Solving, Communication, Collaboration, Process Improvement, Root Cause Analysis, CAPA, Training, Documentation, Attention to Detail, Compliance

Industry

Hospitals and Health Care

Description

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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. tex Job Description 角色与职责新项目执行阶段。验证监管要求是否得到满足，并使客户满意度和盈利能力最大化。扩大本学科的理论、实践和程序知识，以执行职能政策/战略；继续培养职能性知识和技能。理解关键业务驱动力的基础知识；用这种理解来完成自己的工作。了解自己团队的工作如何与其他团队融合并为该领域做出贡献。可能具有一定的自主权，从而在定义的框架内进行决策。以良好的知识和判断力解决在规定程序中遇到的问题。就定义的政策/参数之外的问题咨询更多的高级团队成员。此级别的职位需要良好的人际交往能力。一、生产过程质量保证（Process QA）负责生产现场质量监督，确保生产活动符合 GMP、ISO13485、QSR 等法规要求对关键工序进行巡检、见证、抽查，确保过程受控监督生产环境、人员、设备状态符合质量要求参与生产偏差调查，推动根因分析（RCA）与 CAPA 落地二、文件与体系管理（QMS）参与质量体系文件（SOP、WI、表单）的编写、修订与培训确保生产执行严格遵循 QMS 要求协助管理变更控制、偏差、CAPA、风险管理等质量流程支持内外部审核（监管检查、客户审核、ISO 审核）三、生产质量数据管理参与质量月报、季度报告的编制推动质量改进项目（如流程优化、缺陷减少、合规提升）四、培训与合规对生产人员进行 GMP、质量意识、文件规范等培训监督培训记录的完整性与合规性推动生产团队质量文化建设五、跨部门协作（One Team）与生产、工程、供应链、研发等部门协作解决质量问题参与新产品导入（NPI）和转产项目的质量评估支持设备验证、工艺验证、清洁验证等活动 ✅任职要求（Qualifications）教育背景研究生及以上学历，专业优先：生物工程、医学工程、电气、机械、化学、材料、质量管理等经验要求 1–5 年医疗器械、制药、电子或高标准制造行业 QA/QC/生产经验熟悉 ISO13485、GMP、QSR820、风险管理（ISO14971）者优先有生产现场 QA 或质量体系经验者优先能力要求熟悉质量管理工具（5Why、Fishbone、FMEA、CAPA 等）具备良好的沟通协调能力，能推动跨部门协作具备较强的执行力、问题解决能力、数据分析能力注重细节，具备良好的合规意识与风险意识具备英文沟通能力 ✅ 岗位亮点参与 Class II/III 医疗器械的生产质量管理深度参与 QMS、验证、风险管理等核心质量体系与跨部门团队协作，推动产品质量持续提升直接影响患者安全与产品合规性，使命感强 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 At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.

Responsibilities

The QA Engineer is responsible for ensuring that production activities comply with regulatory requirements and for overseeing quality assurance processes. They will also participate in quality system documentation and support internal and external audits.