Ambu
Overview
In this role you drive quality management across software development and AI-enabled medical devices, ensuring compliance throughout the lifecycle. You will support global R&D initiatives and collaborate with cross-functional teams to integrate quality, regulatory, and cybersecurity requirements. Your work shapes safe, effective software solutions within Ambu’s EndoIntelligence platform and broader strategy. You’ll contribute to design controls, risk management, and post-market surveillance to sustain high patient care impact.
Leistungen / Benefits
- professional development opportunities
- dynamic, international work environment
- collaborative team culture
- diverse and inclusive workplace
- employee benefits—professional, social, and financial
Verantwortungsbereiche
- Quality management support for software development and AI-related R&D projects
- Leading and supporting risk management activities for software-based devices
- Integrating cybersecurity considerations into product development and maintenance processes
- Providing quality oversight for AI-enabled medical device software, including lifecycle controls, documentation, traceability, and change management
- Supporting design control, lifecycle management, design changes, and post-market surveillance activities
Zentrale Anforderungen
- Strong foundation in quality engineering/management within regulated medical device or digital health contexts
- Hands-on experience with software development projects in regulated environments
- Solid knowledge of SaMD or software embedded in medical devices
- Experience with AI-enabled products or relevant quality/regulatory expectations for AI/ML medical software
- Understanding of risk management including safety and cybersecurity risks
- Knowledge of IEC 62304, ISO 14971, IEC 81001-5-1, ISO 13485, EU MDR, MDSAP, UK MD, QMSR
- Understanding of EU AI Act implications for high-risk AI systems in health/medtech is a strong advantage
- Proactive mindset
- Cross-functional collaboration
- Communication and stakeholder management
- Quality Engineering / Quality Management in regulated environments
- Software as a Medical Device (SaMD) and medical device software
- AI/ML for medical software