1. Management and development the project and product quality assurance team, build up the team competence on internal quality management system and international quality standards.
2. Design, integration and optimization of software design and development processes for Quality Management System according to business development needs and international quality regulations.
3. As the quality interface with R&D quality team of Germen DS QT, harmonize and cooperate on quality issues, process and projects.
4. Participate and handle the internal/external audits and management reviews, initiate continuous improvement.
5. Ensure that product engineering process(PEP) is strictly followed by project team and all quality requirements are fulfilled wherever necessary.
6. Work closely with project team and participate in the review and evaluation on relevant documentation coming from different stage of development.
7. Monitor iteration control process is properly followed for software design or development process change.
8. Monitor development quality, initiate data anaylsis, support corrective and preventive actions if necessary.
9. Work closely with partner management cross function team, to ensure all partners product development processes in compliance to internal quality regulation.
10. Monitor the customer feedback from post maket, participate the complaint, adverse event and reporting recall handling.
Experience in software development project management and familiar with Agile development methodology.
Experience with product quality management, process quality control and post market.
Experience with quality control for new product development project from requirement definition to product release.
Experience on establishment and optimization of software design and development processes for Quality Management System.
Experience on people management.
Bachelor degree is required, major in technical (SW, HW, E&E ), project management and/or advance degree is preferred.
Certificate on ISO9001, ISO13485 or QSR820.
Job ID: 102643
Organization: Siemens Healthineers
Company: Siemens Shanghai Medical Equipment Ltd.
Experience Level: Experienced Professional
Job Type: Full-time