SHL Post Market Surveillance Specialist
We at Siemens Healthineers™ are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind. While we are invested in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also deeply invested in our 46.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in this industry. And as we strive to shape the future of healthcare, our overall success will depend on our ability to continuously reinvent ourselves.
If you are ambitious and change makes you thrive, help transform Siemens Healthineers into a learning organization:
1. To support establish and maintenance PMS related SOP and/or system to be consistence with latest regulation and QMS request.
2. To responsible for monitoring and follow up of complaint case related potential AE case from China market.
3. To maintain the recall system in China, including but not limited to report liability to local FDA authority, follow up of recall/field action status, communication with factories and the closure of recall case.
4. To handle the adverse event report system, report the domestic adverse event to local authority, review and check global doubt AE report, and responsible for the document submission and final reporting. Report on Quality System effectiveness and requirements to Head of QA.
5. To take the responsibilities of PMS related training.
6. Be coordinator of after-market related quality issue.
7. Other duties assigned by line manager.
This position may suit you best, if building learning organizations is your expertise and you have extensive experience with Top Management Learning and Leadership Development.
- Bachelor degree or above with major in medical/ biological related
- Above 3 years years experience in PMS/QMS/EHS/SEC&CR,over 5 years ISO14001/OHSAS18000/ISO9001 Auditor
- Highly skill in understanding in Quality & EHS certifications are desirable. (i.e. ISO 14001internal auditor, OHSAS18000 internal auditor,CQE, Green/ Blace Belt, TTT etc.), but not required.
- Excellent in providing training and workshop, computer literacy and consultation
- Highly verbal and written communication skills in English as well as Chinese
- Able to work under pressure
Job ID: 89683
Organisation: Siemens Healthineers
Experience Level: Experienced Professional
Job Type: Full-time