Director of QARA (Engineering) – AI SaMD Quality Leader

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

Job summary

Sword Health is seeking an experienced Director of QARA (Engineering) to define and lead our end-to-end quality strategy across SaMD software, AI/ML, and connected-device products, reporting to the VP of QARA.

You will own verification and validation, risk analysis per ISO 14971, define V&V strategies, and embed quality into the SDLC with CI/CD gates, audits, and regulatory submissions, coordinating with Engineering, Product, and AI teams to move fast and stay compliant.

Qualifications

• 7+ years in software quality engineering, with 5+ years leading quality organizations in a regulated environment.
• Hands-on experience with medical device software or comparable regulated domains, including IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR and EU MDR.
• Proven track record building and scaling test automation and CI/CD quality practices across multiple product teams.
• Experience defining V&V strategies and producing evidence that stood up to audits or regulatory submissions.
• Strong technical credibility: able to review architectures, test frameworks, and code, and to coach engineers.
• Demonstrated people management capability, with a track record as a Team Lead or manager.
• Excellent communication and influence skills, with the ability to work with executives, engineers, clinicians, and regulators.

Responsibilities

• Help set the vision for quality in software/AI engineering across web, mobile, backend, firmware/hardware integration, and AI.
• Own software verification and validation (V&V) strategy for SaMD, ensuring traceability from requirements to test evidence.
• Help define how AI/ML systems are tested and monitored: model validation, dataset quality, bias and robustness testing, regression across versions, post-deployment monitoring.
• Embed quality into the SDLC: shift-left practices, CI/CD quality gates, automated regression, performance, security, accessibility testing, and fast, auditable release processes.
• Work within QARA to keep engineering processes aligned with the Quality Management System and serve as a technical authority during audits by notified bodies and authorities.
• Drive risk-based thinking with product and clinical teams on risk analysis, hazard mitigation, and verification of risk controls under ISO 14971.
• Evaluate and introduce tooling for test management, automation, and traceability.

Skills

Quality engineering

V&V strategies

Regulatory knowledge

CI/CD

Test automation

Code review

Communication

Tools

CI/CD pipelines

Job description

Sword Health is seeking an experienced Director of QARA (Engineering) to define and lead our end-to-end quality strategy across SaMD software, AI/ML, and connected-device products, reporting to the VP of QARA.

You will own verification and validation, risk analysis per ISO 14971, define V&V strategies, and embed quality into the SDLC with CI/CD gates, audits, and regulatory submissions, coordinating with Engineering, Product, and AI teams to move fast and stay compliant.