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.

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) and Software engineering best practices
Agile methods / TIR45
Experienced in end-to-end AI lifecycle processes, including data management, model development, validation, deployment, monitoring, and change management.
Supports teams in implementing AI governance practices, documentation requirements, and lifecycle controls for AI-enabled products.
Reviews AI-related assessments, identified risks, performance issues, and compliance gaps, and supports appropriate corrective actions.
Supports maintenance of AI-related documentation and records to ensure audit readiness and regulatory compliance.

Knowledge :

Implementing ISO 9001, 13485, ISO 14971, IEC 62304 & IEC 82304 within projects
Compliance of requirements from MDR, QSR
Non-regulated software like Apps for Apple / Android
Strong knowledge of AI governance frameworks, AI lifecycle management processes, and AI risk management principles.
Knowledge of regulatory expectations for AI-enabled healthcare products across global markets, including FDA, EU, and other international regulators.
Familiarity with AI-related standards and guidance such as ISO/IEC 42001, ISO/IEC 23894, ISO 14971, GMLP (Good Machine Learning Practice), and applicable AI regulatory frameworks.
Understanding of how AI requirements integrate with medical device quality systems, software lifecycle processes, and regulatory documentation.

Project Quality Engineer - with AI Process Specialist

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