Quality System Manager

Benefits

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Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Establishes the defined Quality Management system tailored/aligned to the project-specific requirements to ensure process and product quality in service/solution project to achieve customer satisfaction and business success. Acts as a member of the project core team with special focus on failure prevention. Advocates to a higher quality aspiration. The Quality System Manager plays a critical role in advancing quality systems, regulatory compliance, and business performance for software-based medical device development. This position is responsible for driving quality strategy execution in alignment with site quality management and business leadership priorities, while ensuring compliance with applicable international regulations, standards, and global regulatory expectations. Key responsibilities include: Lead the establishment, implementation, and maintenance of quality system requirements and business objectives for medical device software and Software as a Medical Device (SaMD) development projects in alignment with applicable procedures, regulations, and international standards. Develop, mentor, and lead a team of quality professionals to support compliance, business growth, product quality, and customer experience. Drive continuous improvement initiatives and organizational change efforts that enhance business agility, quality performance, and operational effectiveness, including through the CAPA system. Partner effectively across functions to identify and address quality risks, business opportunities, and process improvement priorities. Implement process and compliance improvements, leverage AI-enabled tools where appropriate to improve productivity and provide guidance or training on new and revised regulatory standards, quality procedures, and process changes. Authorize and oversee software design projects in accordance with the quality management system and applicable product standards, including leading design reviews at key development stages. Serve as a primary point of contact for escalations and cross-functional issues related to software design and engineering projects, ensuring timely and effective resolution aligned with quality requirements and business values. Apply strong analytical skills to assess quality data, identify trends and compliance risks, and drive improvement actions through quality plans and CAPA activities. Manage Design History Files (DHF) and technical documentation to ensure ongoing compliance with applicable regulations, and coordinate regulatory submissions required for product or process approvals, certifications, or licenses. Lead Quality Review Board activities by presenting meaningful quality metrics and trends to support data-driven decision-making, corrective actions, and preventive actions. Plan and coordinate internal and external audit activities for the site and collaborate with global teams and external agencies as part of broader quality audit programs. Qualifications and Experience : Bachelor's or master's degree in computer science, information technology, software engineering , or a related technical field is required. 8-10 years of experience in the healthcare IT or medical device industry, preferably in software medical device or SaMD environments across software development, quality assurance, verification and validation, and deployment. 3-4 years of people management experience, with demonstrated success in leading, coaching, and developing quality professionals. 2-3 years of experience as a quality systems auditor, including lead auditor certification from a recognized institution. Experience establishing and maintaining quality management systems in healthcare IT or SaMD environments is strongly preferred, particularly within radiology or radiation therapy domains. Professional certifications such as Certified Internal Auditor, Lead Auditor fo r ISO 13485, MDSAP, IEC 62304, Software Quality Assurance (SQA), FDA 21 CFR Part 820, or EU MDR are highly desirable. Hands-on end-to-end software development lifecycle experience is preferred, including software design quality assurance, risk management, post-market surveillance, supply chain quality, and regulatory submissions. Experience working in Agile or Scrum development environments with Artificial Intelligence (AI) tools is preferred. Attributes and Skills : Strong working knowledge of applicable medical device regulations and standards, including FDA regulations, ISO 13485, ISO 14971, IEC 62304, MDSAP, and EU MDR . Solid understanding of the software development lifecycle, software quality assurance principles, and SaMD regula

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