- Salary
- $95k – $115k/yr
- Location
- Golden, CO
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Quality & Regulatory
- Seniority
- Senior
- Education
- Bachelor
- Source
- Lever
Description
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.