SSMR MR Quality Engineer (DCU) 客诉质量工程师
Sunzhen (Weinan Shi) IT development
Job description
Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world?
At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
Mission:
Professional feedback and complaint handling to satisfy the customer and improvement of the quality of our products. 专业地反馈和处理抱怨以提升客户满意度和产品质量
Responsibilities:
1. Professional complaint handling to satisfy the customer and meet the national regulation /专业地反处理抱怨以提升客户满意度和满足法规要求；
2. Do risk assessment for safety-relevant complaints and stipulation of countermeasures/对安全相关的抱怨和对策约定的风险评估；
3. Work with SHS region unit for Adverse Event and Field Safety Corrective Action reporting/与西门子医疗区域部门合作处理不良事件和场地安全更新的上报；
4. Define and follow-up the error-analysis and solutions for hardware and software topics via the involvement of the responsible development departments or suppliers/与相关部门或供应商合作制定与跟进硬件和软件的错误分析和解决方案；
5. Review start-up reports and safety related test reports and escalate if necessary/ 评审启动报告和安全相关的测试报告，并在必要时将问题升级；
6. Statistical analysis of post marketing relevance data for early warning and improvement of product quality/对上市后相关数据进行统计分析，以预警和改进产品质量。
Requirements:
1. Medical device product knowledge/医疗器械产品知识
2. Bachelor degree with 3+ years working experience/本科学历，至少3年以上工作经验
3. Procedure & standards understanding (ISO9001, ISO13485, ISO14971,QSR, etc.)/程序和标准的理解
4. Knowledge of quality methods like 8D,5Why,Fishbone,etc/熟悉质量工具如8D,5Why,鱼骨图等方法
5. Statistical methods and data analysis capability is preferred /培训能力
6. Fluent in English (spoken and written)/流利的英文（听说读写）
7. Effective communication and coach skill/有效的沟通和指导技巧
Our global team:
We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. We aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our Culture:
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.
To all recruitment agencies:
Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.