Company Description
We are one of the largest global suppliers of healthcare equipment, renowned for innovative products, services and solutions including diagnostic imaging systems, therapy equipment for treatment and electromedicine and IT solutions to optimize workflow and increase efficiency in the healthcare industry.
Siemens is an Equal Opportunity Employer encouraging diversity in the workplace.
Job Description
Overall responsibility for the Quality Management & Regulatory Affairs (QM&RA) team within the HS Quality System Management group. Overall, ensures the establishment and maintenance of the Quality Management and regulatory procedures and processes across Health Services, globally, that meet all required standards and regulations for the markets that are served (i.e. ISO, FDA, MDD, etc.) and that protects intellectual property, allows international market access for HS products; and that drives business value through continuous improvement and process automation.
Sr. Director Quality and Regulatory
Key areas of responsibility:
1 Quality Management System: Sets the direction and strategy for the HS Quality Management System. Participates in Quality Management Reviews. When necessary communicates to authorities, or to certification body (e.g. Audits, QMS changes).
2 Process Management: Establish quality management and regulatory-specific requirements and processes that meet all applicable QMS requirements, including definition, documentation, and implementation (training). Collect process metrics, analyze process performance, and identify areas for improvement for QM&RA topics. Lead improvement efforts using industry standard techniques, such as Lean Six Sigma.
3 Regulatory Affairs: Drive the regulatory strategy for products within the HS portfolio through detailed analysis of product strategy, market strategy, and regulatory environment. Ensure the implementation of the required regulatory-specific requirements and processes are met, including completion of the Regulatory Classification Report. Provide approval of quality gates and decision points, where applicable.
4 Audits and CAPA: Establishes and manages the HS Audit Program. Collect audit program metrics, analyze audit program performance, and identify areas for improvement. Identify systemic issues and open CAPA's as appropriate.
5 Leadership and Management: Leads the overall operation of QM&RA with strategic impact including resource strategy and allocation. Provides planning and oversight of all the team’s activities. Manages employee performance and development. Provides leadership to teams/team members on the more complex activities. Strategically leads resolution of complex problems related to multi-departments and/or cross-functional areas. Leads cross-functional/organizational initiatives related to QM&RA.
Overall competencies:
* Thorough knowledge and understanding of FDA QSR and ISO and its application / implementation in a software business
* Thorough knowledge and understanding of the Siemens organization, the HS organization and HS business processes
* Thorough knowledge and understanding of process management and improvement methodologies (such as Lean Six Sigma)
Edge: Strategic Judgment and Risk Management
Energy: Initiative and Change Orientation
Energize: Communcation Skills and Coaching / Mentoring
Execute: Decision Making and Results / Quality Orientation
Passion: Siemens Values
