Hybrid Senior SaMD Quality Engineer

RapidAI; Golden (CO); Hybrid; USD 95,000 - 115,000; Full time

Job summary

RapidAI is seeking a Senior Quality Engineer to guard patient safety and product excellence across our SaMD portfolio. You will embed with Engineering, Clinical, and Product teams to ensure safety, efficacy, and regulatory compliance from concept to global release.

You will champion design controls, lead risk management, oversee V&V, and drive QMS improvements in an agile, AI-first environment with IEC 62304, ISO 13485, ISO 14971, and FDA QMSR awareness. Hybrid work in Golden, CO office required.

Qualifications

• 5+ years of software quality engineering in medical/healthcare tech.
• Hands-on SaMD standards knowledge (IEC 62304, ISO 13485, ISO 14971).
• Experience with design controls, DHF/RTM, risk docs, and V&V reports.
• Proven root-cause analysis and CAPA in collaboration with engineering teams.
• Excellent written and verbal communication; cross-functional accountability.
• Detail-focused with ability to thrive in fast-paced sprints.

Responsibilities

• Lead QA for SaMD across SDLC with IEC 62304, ISO 13485, FDA rules.
• Establish design controls, RTM traceability, and risk mitigations.
• Drive risk management per ISO 14971 with RCA and CAPA.
• Oversee V&V plans, protocols, and regulatory submissions support.
• Manage defects, deviations, RCAs and corrective actions to closure.
• Validate test tools and automation infrastructure (CSV compliance).
• Collaborate with R&D, Platform Eng., Clinical, Regulatory for quality gates.
• Support internal and external audits and continuous QMS improvements.

Skills

Software QA

Regulatory compliance

Risk management

RTM

V&V

CAPA

Cross-functional

Documentation

Education

Bachelor of Science in Biomedical Eng., CS, SE, EE or related

Tools

Jira

GitHub

Propel

TestRail

Job description

RapidAI is seeking a Senior Quality Engineer to guard patient safety and product excellence across our SaMD portfolio. You will embed with Engineering, Clinical, and Product teams to ensure safety, efficacy, and regulatory compliance from concept to global release.

You will champion design controls, lead risk management, oversee V&V, and drive QMS improvements in an agile, AI-first environment with IEC 62304, ISO 13485, ISO 14971, and FDA QMSR awareness. Hybrid work in Golden, CO office required.