Director of Quality (AI)

Location: Boston, Massachusetts, United States; hybrid schedule, Monday–Friday.

Salary: $150,000–$185,000 per year, plus equity options; compensation depends on experience level.

Company

hirify.global builds compliance software that helps teams create safe, secure, and reliable medical software for patients and providers worldwide, including software incorporating AI/ML.

What you will do

• Own the Quality Management System and support the Information Security Management System by maintaining effective, scalable, and audit-ready policies, SOPs, and records aligned with ISO/IEC 27001 and SOC 2 programs.
• Lead AI governance, including AI policies, ISO/IEC 42001 conformity, and assurance expectations for validated AI agents.
• Lead readiness and execution for ISO 13485, IEC 62304, ISO 14971, ISO/IEC 27001, SOC 2, IEC 61508, and ISO 26262 certifications, as well as customer audits and supplier assessments.
• Define risk-based change and release gates, evidence expectations, and release-level risk assessments.
• Maintain validation packages and the trust center, and support compliance questionnaires, RFPs, and strategic customer accounts.
• Monitor requirements such as EU MDR, the EU Cyber Resilience Act, and 21 CFR Part 11; lead the QA/RA consulting team and collaborate with Engineering, Product, Security, Sales, and leadership.

Requirements

• 10+ years of quality experience in a MedTech, BioPharma, or Life Sciences company.
• Experience operating or leading a QMS and supporting external audits in a regulated environment.
• Experience owning or materially supporting an ISMS under ISO/IEC 27001 or an equivalent standard.
• Strong command of risk-based quality practices and change and release governance.
• Clear communication with technical and non-technical audiences and strong documentation skills.

Nice to have

• Hands-on audit experience across ISO 13485, IEC 62304, ISO 14971, ISO/IEC 42001, IEC 61508, ISO 26262, and SOC 2.
• Experience with AI governance and validating AI-enabled features.
• Experience supporting customer validation and security questionnaires for enterprise SaaS.
• Familiarity with functional safety tool qualification.
• Experience leading quality or regulatory professionals.

Culture & Benefits

• Competitive compensation and possible stock options.
• Generous PTO for full-time employees.
• Opportunity to learn and grow as part of a global team.
• Work focused on improving the safety and reliability of medical software.