Quality Professional

Roles 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

Measures of Performance

Skills Required

Software Quality Assurance, Iso 13485, Iso 9001, 21 Cfr Part 11