3h 25m ago
Senior Quality Engineer
Hybrid
|United States of AmericaSenior Quality Engineer
RapidAI | Healthcare AI
3h 25m agoHybrid
Full Time
IC
United States of America
RapidAI is the trusted leader in deep clinical AI, helping hospitals deliver faster, more informed care through intelligent imaging and integrated workflows. The Rapid Enterprise™ Platform supports disease states across the care spectrum, but it’s our clinical depth that drives the most meaningful impact — improving decision-making, patient outcomes, and health-system performance. Used by more than 2,500 hospitals in over 100 countries and backed by 700+ clinical studies, including research that helped expand national stroke-treatment guidelines, RapidAI is the most clinically validated AI platform in healthcare.
As a Senior Quality Engineer at RapidAI, you will serve as an essential guardian of patient safety, compliance, and product excellence across our industry-leading Software as a Medical Device (SaMD) portfolio. You will embed directly with Engineering, Clinical, and Product teams to ensure our cutting-edge AI diagnostic and workflow solutions meet the highest standards of safety, efficacy, and regulatory compliance from initial concept through global release.
In this role, you will champion robust design controls, lead risk management initiatives, oversee verification and validation (V&V) activities, and continuously refine our Quality Management System (QMS). Working in an agile, AI-first environment, you understand that rapid product iteration must go hand-in-hand with uncompromising regulatory rigor (IEC 62304, ISO 13485, ISO 14971, and FDA QMSR / 21 CFR Part 820).
Work Location:This role requires a hybrid work location arrangement. You will be required and expected to be present and work in the Golden office (1120 Washington Ave, Golden,CO 80401)up to 3 days per week, and as needed for department or functional project meetings. On days when you are not required to be in the office, you will have the flexibility to work remotely, subject to the needs of the team and business.
Required Languages
🇬🇧 English