- Quality Management System: Develop, establish, maintain and optimize a consistent QMS, including required certifications based on internal and external quality/regulatory related requirements. Ensure that Siemens requirements and the roles and responsibilities of Siemens QM are fulfilled. Coordinate and influence activities towards 3rd parties. Ensure corporate compliance concerning product safety.
- Quality Planning: Ensure business-driven quality planning in SHDM and if necessary, an integrated quality plan. Ensure (a) identification of critical business issues, (b) prioritization of improvement projects / actions, (c) realistic budget and resource planning, (d) selection of financial and non-financial KPIs, (e) benchmarked target values and, (f) the coordination of personal quality related targets for management, individuals and / or teams. Drive non-conformance costs (NCC) as one quality focus topic.
- Quality Reporting: Drive QA/QE/QC and RA team to control fulfilment of quality/regulatory requirements and performance. Design of an appropriate quality information system including KPIs. Deliver quality performance reporting to SHDM General Manager for evaluation and to initiate improvement activities. Preparation and conduct of management reviews. Provide broad communication of quality topics and metrics to all employees.
- Customer Integration: Facilitate methodologies to analyse customer requirements appropriately in order to meet customer expectations and to identify relevant KPIs for the quality reporting. Foster regular customer integration as well as professional feedback and complaint handling to achieve high customer satisfaction / retention. Ensure escalation process with fast complaint routing and consequent root-cause analysis.
- Quality in Processes and Projects: Ensure and control implementation of quality tools in processes / projects, e.g. quality gates. If necessary, use authority to refuse development, production, shipping and acceptance release.
- Continuous Improvement: Plan, initiate and coordinate continuous improvement activities with SHDM management. Provide concepts including organizational roles, integration in process and project design, pragmatic tools, assurance of management attention and sufficient resources. Initiate best practice sharing.
- Qualification for Quality: Coordinate with HR to implement a competency management for SHDM and training system to ensure employee role-based required training is identified. Design, develop and deliver SHDM quality, process and regulatory topics, including related tool training. Deploy strategies to identify competency gaps and evaluate the effectiveness of the competency management program.
- Audits and Assessments: Plans and performs audit program (including certification audits where applicable) and assessments from authorities. Recommend improvement actions and ensure follow up controlling.
- Communication regarding Quality: Implement communication strategy and plan to ensure a SHDM wide understanding of the Siemens quality framework and culture including SHDM specific quality topics. Ensure external communication towards customers, suppliers (aligned with Procurement) and to external authorities are controlled. Represent SHDM general manager regarding QM topics as SHDM quality management representative.
- Regulatory Requirements: ensure SHDM regulatory requirements are well defined, processes are developed to meet requirements, resources are aligned to ensure requirements are met, and where required, interfaces are developed.
- Drive for SHDM product license clearance from NMPA (SHFDA)
- Other related projects or tasks assigned by superior or company.
- A minimum of 10 years in the medical device industry with at least 5 years in a quality system management role. Prior IVD reagent experience highly desired.
- Experience in hosting/participating in quality system inspections, e.g., CFDA, Notified Bodies.
- Prior experience with facility start-ups and quality system implementation is a plus
- Quality system auditing experience and prior experience in an IVD manufacturing environment is preferred
- A minimum of a 4 year degree, preferably in biology or life science discipline.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai
Experience Level: Experienced Professional
Job Type: Full-time