The mission for a senior quality engineer is to operatively establish, maintain and optimize
a Quality Management System (QMS), make sure that all processes/projects are in
compliance with quality and regulatory requirements, control and improve product
quality.

Areas of Responsibilties:
• 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 line in Germany and participation on influencing activities towards 3rd parties.
• Ensure quality and regulatory requirements are defined, processes are developed to meet
requirements.
• Ensure implementation and controlling of quality gates and preventive quality tools to gain
a sustainable higher quality in the processes/projects. This requires personal involvement
in processes and projects.
• Regular internal assessments based on relevant quality standards. Direct report to the
heads of SHS DI D&A QT QA CHN Head 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.

• authorities:
- As a independent quality function to review development documents.
- Intervention, overruling and escalation in case of process non-compliance.
- 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 ofSHS DI D&A CHN 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 SHS DI D&A CHN product modification when necessary.
• Other tasks assigned by supervisors.

Education and Experience
• More than 3 years experience with quality management in similar industry.
• Experience with processes/quality control in product lifecycle management.
• International project/process experiences in quality subjects of foreign countries and companies.
ISO9001, ISO13485, CGMP, MDD 93/42/EEC, MDR, 21 CFR part 820, MDSAP
etc Procedure & Standards understanding.