DTx Quality Engineer

Role Title: DTx Quality EngineerLocation: Remote (US-based candidates preferred)Contract: 6 months | ~25 hours per week/ 40hours per weekStart Date: End of March 2026Key Must-Have Experience:Strong background in Software as a Medical Device (SaMD)Experience operating at the intersection of software development, regulatory compliance, and quality systemsHands-on experience with:21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, Part 11Design controls, traceability, verification & validation documentationAgile/DevOps environmentsRisk Management (hazard analysis, risk file maintenance)Complaint Handling (intake, investigation, RCA, CAPA input, regulatory assessment, closure)Post-market surveillance & trendingAbility to maintain inspection-ready documentationRole Allocation:75% - DTx-related quality & lifecycle management25% - Quality Complaint Management