Mission and Position headline:
The mission for a quality manager is to operatively establish, maintain and optimize a Quality Management System (QMS), make sure that all processes/projects are following quality and regulatory requirements, control and improve product quality. He/she consults the SSME D&A management (GM, Heads of R&D and supporting functions etc.) regarding current and future quality/regulatory requirements and risks. He /she reports directly to the head of SSME D&A QT.
Your tasks and responsibilities:
• Ensure (a)definition and identification of the scope of quality management, (b) prioritization of improvement projects/actions.
• Development, implementation, and documentation of a consistent quality management system based on regulatory and quality related requirements and in alignment with the Siemens process framework. Interaction with QM of business unit in Germany and participation on influencing activities towards 3rd parties. Ensure corporate compliance concerning product safety.
• Ensure quality and regulatory requirements are defined, processes are developed to meet requirements, resources are aligned to ensure requirements are met, and where required, interfaces are developed.
• Ensure implementation and controlling of quality gates and preventive quality tools to gain a sustainable higher quality in the processes/projects. Initiate continuous improvement with employee support. This requires personal involvement in processes and projects.
• Planning, initiative, and coordination of continuous improvement with management of business unit. Providing concepts and pragmatic tools like clear organizational roles, integration in process and project design, assurance of management attention and enough resources. Initiating best practice sharing.
• Regular internal assessments based on relevant quality standards. Direct report to the heads of D&A QT and business unit with recommendation of improvement actions and their follow up controlling.
• Support and control customer complaint handling process to ensure all customer issues are handled in a timely manner, improve customer satisfaction.
• Ensure supplier management with best management methods in alignment with P, to increase the delivered quality and reduce the cost of non-conformance. This comprises supplier related processes like selection, information, development. integration, monitoring, and auditing.
- Directive leadership towards QM in processes/projects.
- As a independent quality function to review development documents.
- Intervention, overruling and escalation in case of process non-compliance.
- Release and stop of product delivery in D&A.
- Release and stop of material delivery from suppliers.
• Assignment for DCU responsible.
- Be fully responsible for complaint handling process and complaint KPI monitoring
- Take charge of SSME D&A Complaint Handling Board and Safety Council
- Contribute to the risk analysis of safety issue and reporting decision
- Support complaint investigation and approve the final report
- DCU authority: as an independent quality function to decide complaint handling and reporting issue, and to trigger D&A product modification when necessary.
- Other tasks assigned by supervisors
Your qualifications and experience:
• Bachelor’s degree or above.
• More than 5 years’ experience with quality management in healthcare industry.
• Solid Knowledge and experience with processes/quality control in product lifecycle management.
• International project/process experiences in quality subjects of foreign countries and companies.
Organization: Siemens Healthineers
Company: Siemens Healthineers Diagnostics (Shanghai) Co., Ltd.
Experience Level: Experienced Professional
Full / Part time: Full-time