Job ID 1450
We offer you a flexible and dynamic environment where you have the space to stretch beyond your comfort zone in order to grow personally and professionally. Sound interesting?
Then come in and join SSMR as 质量过程管控工程师/Quality Risk Management Engineer to inspire the future of healthcare.
1. Act as process owner of risk management & coach R&D. Ensure the Product Risk Management process complies with all necessary Regulatory Standards e.g. QSR (FDA), MDD and ISO requirements
2. Lead the risk management team on developing and approving Risk Management Files according to ISO14971, which includes risk management plan, product risk analysis, risk mangement report and risk assessment for individual function.
3. Provide technical knowledge to the Risk Management Program including contributing to develop design and process FMEA’s for all manufactured products.
4. Manage and oversee the implementation of effectiveness regarding Corrective & Preventive Actions as they pertain to the risk management program.
5. Before release for volunteer scanning, perform risk assessment on the prototype system.
6. Work together with DCU to handle the safety complaints.
7. Provide internal trainings for product risk management.
8. Perform product risk management activities and reports for post market surveillance.
- Bachelor degree, Engineering background is preferred.
- At least 3 years working experience in R&D, CS or QM.
- Active, self-confident and convince capability, good analysis, result orientation, team work, communication skill, Fluent English.
- Knowledge for MR technology is preferred and relevant standards and method, e.g. ISO14971, IEC60601-1, FMEA
Being part of our team:
Siemens Healthineers is a leading global medical technology company. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Curious about our culture?
Our culture embraces different perspectives, open debate and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas and celebrate success.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
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.
Organization: Siemens Healthineers
Company: Siemens Shenzhen Magnetic Resonance Ltd.
Experience Level: Experienced Professional
Job Type: Full-time