Our client is Siemens Healthineers, a leading global medical technology company with more than 55,000 dedicated colleagues in over 70 countries, driven to shape the future of healthcare.
TASKS AND RESPONSIBILITIES
Elaborates, analyses and implements quality concepts, methods, tools and procedures as part of an effective Quality Management System.
Gives guidance that risks are identified, considered, and controlled throughout the design and the use of the Quality Management system.
Support the Project Manager and Application Manager in activities related to the development and/or implementation of the software-specific quality activities in projects or changes.
Support the QM team in implementation and compliance to ISO9001, ISO 13485 and 21 CFR Part 11 implementation for the assigned projects, applications and changes as defined in ITSM (IT process framework).
Independently perform special assignments and provide reporting of the activities in the project/application.
Anticipate potential quality problems and provide effective solutions in reaction to application of concepts, techniques, knowledge, or processes.
Demonstrate ability to advanced technologies, processes, and practices in quality management. Serve as the leading point of authority and/or source of process knowledge for area of expertise (quality management).
Demonstrate extensive knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues.
Trains employees in a specific quality area in the quality management system.
As Quality Manager collaborate well with the counterpart for BA/BL Quality, where applicable.
Coach the project and application team members in Quality Management System and Processes application.
Being part of the SHS IT ST QGC QS organization support in Project Quality topics, Application lifecycle and ISO certification program.
Coordinate a group of quality-related staff without leading the team.
Coordinate an assigned international/national quality network in a specific quality area.
Ensure the QM network is clearly built and sharing of the knowledge is emphasized across the network.
SKILLS / KNOWLEDGE NEEDED
Fluent English skills, both written and verbal
BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.
Successful experience in Quality Management and successful demonstration of key responsibilities and knowledge as presented above.
You are characterized by your knowledge of relevant QM requirements (ISO standards and laws), have well-founded practical experience in auditing (ISO 9001 and preferably ISO 13485)
Knowledge in CMMI for Services (Capability Maturity Model Integrated) is highly preferred.
Knowledge and experience in methodologies of software Quality Assurance
An understanding of foundational PM principles including management of scope, schedule, budget, risk, resources, quality, communications, suppliers, stakeholders, and team operations.
Expert level of critical thinking in applying principles, theories, and concepts on a wide range of problems.
Experience in continuous improvement processes based on learnings from field issues
Agile or SAFe certification is a plus.