M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You’ll Make in this Role
As a Training Lead, This role is pivotal in bridging compliance, operational excellence, and workforce competency within a high-stakes medical device manufacturing environment. By reducing NCR rates and fostering a quality- culture, you will directly impact patient safety, regulatory compliance, and business profitability.
在高风险的医疗设备制造环境中，这个角色在衔接合规性、卓越运营和员工能力方面至关重要。通过降低NCR率和培养质量的文化，您将直接影响患者安全、法规遵从性和业务盈利能力。
You will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
To establish a systematic training and auditing framework to ensure 100% compliance with ISO13485, GMP and other regulatory requirements, reduces NCR (Non-Conformance Rate), and fosters a safe, efficient, and quality-driven production environment through closed-loop control and a culture of continuous improvement with Dozuki or other e-learning tools framework.
Key Responsibilities:
1. Compliance-Centric Training System Development

● Design and implement SOP training programs aligned with QMS, JSA, QIS, PS, WI, TPM, Earlier detection, Troubleshooting etc standards, covering critical scenarios (e.g., safe operation, cleanroom control, process setting, quality control, product traceability).
● Develop interactive training modules using Dozuki or similar e-learning tools to enhance engagement and knowledge retention.
● Establish regular training mechanism for quick daily communication, monthly systematic learning and quarterly evaluation examination.
2. QMS Implementation & Quality Improvement

● Deliver QMS-related trainings (e.g., internal auditor training, audit preparation and inspection, document control etc) to ensure adherence to quality management system.
● Collaborate with the quality / process team to audit SOP-practice alignment and lead corrective training for non-conformances to workshops.
● Work with quality and process engineers for internal & external complaint OPL (one point lesson) training for complaint reduction.
3. Safety & Efficiency Optimization

● Conduct trainings based on JSA, LOTO and safety requirement in standards.
● Streamline electronic SOP management via Dozuki or similar e-learning tools to minimize human error and improve production yield & productivity by standard work enhancement and effective troubleshootings.
4. Layer Audits, Evaluation System and Close-loop Control for Continuous Improvement

● Establish a multi-tier audit system (daily by shift leader, weekly by production leaders/engineers, monthly by managers) integrating compliance, internal/external audit, production operation, complaint findings etc.
● Setup evaluation system with data driven for training efficiency and operator work license by close-loop control for continuous improvement.
Qualifications
1. Education & Certifications

● Bachelor’s degree + is preferred in Biomedical Engineering, Quality Management, Industrial Engineering, Process Engineering or related fields. F
● ISO 13485 Auditor certification and LSS certification are preferred.
2. Experience & Skills

● 3+ years in medical device manufacturing training, QMS maintenance, or process, quality, production roles.
● Proficiency in e-learning tools (Dozuki, Website application etc) and data analysis software (Microsoft, PBI, Seeq, Ignition, Minitab etc).
● Strong communication skill with cross functional teams in both oral and written – ability to interpret standards, draft training materials, and collaborate with others.
● Expertise in regulatory compliance (ISO 13485, GMP, NMPA / MOH requirement etc) is preferred.
3. Competencies

● Risk-aware mindset with the ability to balance compliance and operational efficiency.
● Systematic problem-solving skills to convert complex issues into standardized solutions.
建立系统的培训和审核框架，确保100%符合ISO13485、GMP和其他法规要求，降低NCR（不合格率），建立Dozuki或其他电子学习工具框架，营造安全、高效、质量驱动的生产环境，提升闭环控制和持续改进的文化。
主要职责:
1. 以合规为中心的培训系统开发

● 根据QMS， JSA， QIS， PS， WI， TPM，早期检测，故障排除等标准，设计并实施SOP培训计划，涵盖关键场景（如安全操作，洁净室控制，工艺设置，质量控制，产品可追溯性）。
● 使用Dozuki或类似的电子学习工具开发互动式培训模块，以提高参与度和知识留存率。
● 建立日常快速沟通、月度系统学习、季度考核的定期培训机制。
2. 质量管理体系的实施和质量改进

● 提供质量管理体系相关培训（如内审要求，审核准备和检查，文件控制等），以确保遵守质量管理体系。
● 与质量/工艺团队合作，审核SOP-操作的一致性，并对不符合项进行纠正培训。
● 与质量和工艺工程师一起进行内部和外部投诉OPL（一点式课程）培训，以减少客户投诉。
3. 安全与效率优化

● 根据JSA， LOTO和安全标准要求进行培训。
● 通过Dozuki或类似的电子学习工具简化电子SOP管理，以***限度地减少人为错误，并通过提高标准工作和有效的故障排除来提高产率和生产率。
4. 层级检查，评价体系和闭环控制，以实现持续改进

● 建立多层检查体系（每日由带班检查，每周由领班/工程师检查，每月由经理检查），整合合规性，内部/外部审核、生产操作和投诉情况等。
● 通过闭环控制，建立以数据为驱动的培训效果和操作工工作许可评估体系，并进行持续改进。
资格
1. 学历及证书

● 本科及以上学历优先，生物医学工程、质量管理、工业工程、工艺工程或相关专业。
● 有ISO13485审核员认证和LSS认证优先。
2. 经验技能

● 3年以上医疗器械制造培训，质量管理体系维护，或工艺，质量，生产岗位。
● 熟练使用电子学习工具（Dozuki， Website application等）和数据分析软件（Microsoft, PBI, Seeq, Ignition, Minitab等）
● 较强的与跨职能团队的口头和书面沟通能力，能够解释标准，起草培训材料，并与他人合作。
● 熟悉法规遵从性（ISO 13485， GMP， NMPA / MOH要求等）优先考虑。
3. 能力要求

● 具有风险意识，能够平衡合规和运营效率。
● 系统解决问题的能力，将复杂问题转化为标准化的解决方案。
Work location: 浦江，上海
Travel: May include up to 35% domestic travel
Must be legally authorized to work in the country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.