Risk management and V&V Engineer - #2761714

Job Requirements

At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

Key Responsibilities

• Lead risk management activities for AI SaMD products (CT/MRI/US imaging) in compliance with ISO 14971.
• Define and oversee verification and validation strategies for AI/ML-based medical software.
• Ensure compliance with IEC 62304, ISO 13485, FDA SaMD guidance, EU MDR, and GMLP requirements.
• Evaluate AI-specific risks, including model performance, bias, cybersecurity, data integrity, and model drift.
• Support regulatory submissions, audits, and post-market surveillance activities.
• Collaborate with Engineering, Data Science, Clinical, Quality, and Regulatory teams to ensure safe and compliant product releases.
  
  

Required Skills

• AI/ML Risk Management
• Software Verification & Validation (V&V)
• Medical Device Regulatory Compliance
• Requirements Traceability
• Cybersecurity & Quality Management Systems
• Stakeholder Management and Cross-functional Leadership
  
  

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.

Qualifications

Work Experience

• 8+ years in Medical Device Software, Quality, Validation, or Regulatory Compliance, with 3+ years in AI/ML-enabled healthcare solutions focused on CT/MRI/US imaging.
  
  

Benefits

• based on seniority and knowledge, our budget for the role is between 65k - 90k Euro gross/year