Director of Quality Assurance for AI-Enabled SaMD

Sword; United States; Remote; USD 72,000 - 114,000; Full time

Job summary

Sword is building AI to heal billions and redefine healthcare through AI Care and SaMD products. We seek a Director of QARA (Engineering) to set the quality vision across AI, software and connected devices, ensuring fast, compliant delivery.

You will own V&V strategy, embed QA in the SDLC, and drive risk-based thinking with cross-functional teams to satisfy regulators and customers alike.

Qualifications

• 7+ years in software quality engineering in regulated settings.
• 5+ years leading quality teams (managers and ICs).
• Experience with medical device software and regulatory standards (IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR, EU MDR).
• Proven ability to scale test automation and CI/CD quality practices.

Responsibilities

• Define the vision for software/AI quality across web, mobile, backend, firmware, and AI systems.
• Own V&V strategy for SaMD with traceability from requirements to test evidence.
• Define testing/monitoring for AI/ML systems, including model validation and drift checks.
• Embed quality into SDLC with CI/CD quality gates and automated testing.
• Work with audits and regulatory submissions to support QA processes.
• Drive risk-based thinking with product/clinical teams and risk controls verification.

Skills

Software quality

Leadership

Regulated environment

Medical device software

V&V

CI/CD

Job description

Sword is building AI to heal billions and redefine healthcare through AI Care and SaMD products. We seek a Director of QARA (Engineering) to set the quality vision across AI, software and connected devices, ensuring fast, compliant delivery.

You will own V&V strategy, embed QA in the SDLC, and drive risk-based thinking with cross-functional teams to satisfy regulators and customers alike.