Quality Professional

As a Quality Manager, your role involves elaborating, analyzing, and implementing quality concepts, methods, tools, and procedures to ensure the effectiveness of the Quality Management System. You will provide guidance to ensure risks are identified, considered, and controlled throughout the design and use of the Quality Management system. Supporting Project Managers and Application Managers in software-specific quality activities, compliance to ISO standards, and special assignments are also key responsibilities. Key Responsibilities: - Elaborate, analyze, and implement quality concepts, methods, tools, and procedures for an effective Quality Management System. - Provide guidance on risk identification, consideration, and control throughout the design and use of the Quality Management system. - Support Project Managers and Application Managers in software-specific quality activities. - Assist in compliance to ISO standards (ISO9001, ISO 13485, and 21 CFR Part 11) for assigned projects and changes. - Independently perform special assignments and provide reporting on project/application activities. - Anticipate quality problems and provide effective solutions using advanced technologies and processes. - Demonstrate extensive knowledge in quality management practices and contribute to issue resolution. - Train employees in specific quality areas within the quality management system. - Collaborate with counterparts for BA/BL Quality and coach project and application team members in Quality Management System and Processes application. - Support SHS IT ST QGC QS organization in Project Quality topics, Application lifecycle, and ISO certification program. - Coordinate a group of quality-related staff and an assigned international/national quality network in a specific quality area. - Ensure the QM network is well-built and emphasizes sharing knowledge across the network. Qualifications Required: - BS/BA in a related discipline, or equivalent combination of education and experience. - 5-8 years of experience in Quality Management with a good understanding of relevant QM requirements and practical experience in auditing (ISO 9001 and preferably ISO 13485). - Knowledge in CMMI for Services and Software Development Lifecycle (SDLC) is highly preferred. - Experience in methodologies of software Quality Assurance and software test automation. - Understanding of foundational PM principles and experience in continuous improvement processes. - Agile certification is a plus. In addition to the above role and responsibilities, the company evaluates your performance based on feedback from change management, key stakeholders, customer satisfaction, and project team satisfaction on the overall quality and effectiveness of process execution.,