jobid
- 455616
jobfamily
- Quality Management
company
- Siemens Shanghai Medical Equipment Ltd.
organization
- Siemens Healthineers
jobType
- Full-time
experienceLevel
- Experienced Professional
contractType
- Permanent
Job Description
Mission/ Position Headline:
- The mission for the Quality Director of SSME CT QA is to operatively establish, maintain and optimize a Quality Management System (QMS) according to the business requirements and the BA/BL directives. At the same time, he/she shall work closely with the Quality Director of SSME QT and CT HQ QT to make sure an effective regulatory affairs management process established, be responsible for completing authority audit, support and execute NMPA(CFDA) license clearance to meet the needs of SSME CT business.
Areas of Responsibilities:
- Quality Management System: Develop, establish, maintain and optimize a consistent QMS in the SSME CT, 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 SSME CT 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: Work closly with SSME QT to control fulfilment of quality/regulatory requirements and performance. Design of an appropriate quality information system including KPIs. Deliver quality performance reporting to SSME CT 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 SSME CT 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. Incorporate the results into the SSME CT quality report.
- Qualification for Quality: Coordinate with HR to implement a competency management for SSME CT and training system to ensure employee role-based required training is identified. Design, develop and deliver SSME CT quality, process and regulatory topics, including related tool training. Deploy strategies to identify competency gaps and evaluate the effectiveness of the competency management program. Ensure qualification and staffing of SSME CT QA positions in operative business and projects.
- 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 SSME CT wide understanding of the Siemens quality framework and culture including SSME CT specific quality topics. Ensure external communication towards customers, suppliers (aligned with Procurement) and to external authorities are controlled. Represent SSME CT general manager regarding QM topics.
- Regulatory Requirements: Work closely with the SSME QT and CT HQ QT team to ensure SSME regulatory requirements are defined, processes are developed to meet requirements, resources are aligned to ensure requirements are met, and where required, interfaces are developed.
- Drive and execute CT products license clearance from NMPA
- Authorities:
- Directive leadership towards QM in processes/projects
- Intervention, overruling and escalation in case of process non compliance.
- Release and stop of delivery.
- Access to all quality relevant data e.g. customer contracts, risk assessments, financial data, project plans, target settings.
- Internal and external representation of the SSME CT general manager in case of quality.
- Other tasks assigned by supervisors.
Dimension of Function/Volume:
- Full responsibility for the QMS of SSME CT and its effectiveness. Definition of policy and operational targets related to customer satisfaction, fulfilling regulatory requirements, process and product quality for agreement by SSME CT Head. Regular reporting on target achievement and performing management reviews with SSME CT management.
Contacts (internal/external):
- Internal: Key function owners such as line function and central function and to responsible of processes/projects owners.
- External: Customers(e.g. sales support, complaint and satisfaction management) and suppliers (e.g. workshop/audits at suppliers for evaluation and development). Gov. authorities.
Education and Experience
- >5 Experiences in leading Quality related teams in a Multi-national company.
- >5 years Experiences on PLM/SCM function area or projects as a plus
- At least bachelor degree with engineering background.
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