SHS AT QT (Advanced Therapies Quality & Regulatory Team) is a global organization focused on ensuring product quality, regulatory compliance, and patient safety across the product lifecycle. It supports innovation by integrating Quality Engineering, Risk Management, Reliability Engineering, and regulatory expertise into product development. The team drives digitalization, AI adoption, and continuous process improvement to enhance efficiency and compliance. SHS AT QT aims to deliver high-quality healthcare solutions faster, enabling better outcomes for patients, customers, and healthcare providers worldwide.
Responsibility for
• Analyzing, collecting data, and providing accurate, documented information about the status of quality
• Verifying the correctness of quality related development results in compliance with the Quality Management Plan & authorize their release for medical devices
• Validation of compliance to basic requirements, e.g. ISO standards and regulations like Medical Device Regulation (European Union Regulation), Quality system regulation (US FDA)
• Assessment of completeness of Design history file and Device master records?- Participate in reviews as per QMS, external and internal audits
• Provide process expertise and guidance for AI-enabled products throughout the development and maintenance lifecycle.
• Assess and improve AI governance, risk management, and lifecycle management processes to ensure effectiveness and compliance.
• Review AI-related documentation and evidence to support product releases, regulatory submissions, audits, and technical file updates.
• Facilitate alignment of AI development activities with applicable quality, regulatory, and organizational requirements.
Work Experience
Experienced in:
• Product risk management & non-product software validation processes for medical devices
• Creation and maintenance of technical file/summary technical documentation (STED)
• Medical device development (including SW)