1. Timely track global PMS regulation regulation; analysis and planning of implementation and lead implementation;
2. Timely make decision and timely reporting of MDR and FSCA to global RA and communication and confirm and archive reporting with global NCA (eg. FDA, NMPA, EU)
3. Timely handling complaints and organize investigation, solutions and feedback to customer
4. Analysis and trending post market quality data in order to improving product quality
5. Establish, maintain and optimize PMS related process, at least complaint handling, reporting, recall, advisory letter, etc.
6. Coordination of and contribution to solve quality problems according to e.g. 8D-methodology and drive projects to solve the problems sustainably.
Organization: Siemens Healthineers
Company: Siemens Shenzhen Magnetic Resonance Ltd.
Experience Level: Experienced Professional
Job Type: Full-time