Quality Manager
Education Requirements:
Doctoral degree (PhD) in a technical or scientific field (AI, machine learning, signal/speech/image processing, NLP)
Proven scientific achievements and publications in peer-reviewed journals or international publications
Experience Requirements:
Experience working with quality management systems (QMS) in software or medical devices
Experience with ISO 13485, ISO 14971, and IEC 62304 standards
Participation in the preparation of technical and quality documentation for clinical trials or certification processes
Other Requirements:
Knowledge of modern machine learning and deep learning methods (CNN, sequential models, NLP, behavior analysis)
Knowledge of explainable artificial intelligence (XAI) and model interpretability
Knowledge of AI system design, evaluation, and testing (security, risk, bias, fairness, ethical aspects)
Knowledge of GDPR and Good Clinical Practice (GCP)
Responsibilities:
Overseeing the development and validation of AI algorithms and their integration into medical device software
Ensuring compliance of software development processes with QMS and relevant standards
Collaborating with the R&D team to define requirements for AI components
Co-creating and reviewing technical and quality documentation for registration and clinical trials
Participating in design reviews, internal audits, and preparing for external audits
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