Director of Quality

Job Title: Director of Quality
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $150,000 - $185,000, plus equity options. (Compensation dependent on experience level)

The Director of Quality owns Ketryx's Quality Management System (QMS), Information Security Management System (ISMS), AI governance program, and certification portfolio. This leader keeps our processes effective, scalable, and audit-ready while helping the business ship and serve enterprise customers efficiently. Because Ketryx builds compliance software for regulated industries, the role is also an internal reference user of our platform and a public voice on quality and regulatory practice.

What You'll Do

• Own the QMS and support the ISMS: Keep policies, SOPs, and records aligned with how we operate, including ISO/IEC 27001 and SOC 2 programs.
• Lead AI governance: Own AI policies and ISO/IEC 42001 conformity, and set assurance expectations for validated AI agents.
• Run audits and certifications: Lead readiness and execution for ISO 13485, IEC 62304, ISO 14971, ISO/IEC 27001, SOC 2, IEC 61508, and ISO 26262, plus customer audits and supplier assessments.
• Govern change and release: Define risk-based gates and evidence expectations, and own release-level risk assessments.
• Enable customers and deals: Maintain validation packages and the trust center, and support questionnaires, RFPs, and strategic accounts where compliance is a blocker.
• Track regulation: Monitor emerging requirements (e.g., EU MDR, EU Cyber Resilience Act, 21 CFR Part 11) and translate them into internal and customer guidance.
• Lead the QA/RA consulting team: Staff engagements, set deliverable standards, provide final review, and develop consultants.
• Partner across the company: Work with Engineering, Product, Security, Sales, and leadership, and represent Ketryx externally through content, conferences, and standards work.

How Success Is Measured

• Zero major nonconformities in certification audits, with findings closed on time
• All committed certifications achieved or maintained, including ISO 26262 by August 2027
• Validation packages and risk assessments published for every platform release
• Fast, reliable responses to customer compliance inquiries and deal blockers
• High-quality consulting deliverables with zero quality-related escalations

What We're Looking For

• 10+ years of experience in quality at a MedTech, BioPharma, or Life Sciences company
• Track record 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 equivalent
• Strong command of risk-based quality practices and change and release governance
• Clear communicator with technical and non-technical audiences, with 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
• Background supporting customer validation and security questionnaires for enterprise SaaS
• Familiarity with functional safety tool qualification
• Experience leading a team of quality or regulatory professionals