Director of Quality

Ketryx•Boston, MA

19d•Hybrid

About The Position

The Director of Quality owns Ketryx’s Quality Management System (QMS), supports its Information Security Management System (ISMS), leads its AI governance program, and manages its certification portfolio. The role keeps processes effective, scalable, and audit-ready while helping the business serve enterprise customers efficiently. As Ketryx builds compliance software for regulated industries, the Director also serves as an internal reference user of the platform and a public voice on quality and regulatory practice. The Director leads audit and certification readiness and execution across quality, information security, AI governance, and applicable industry standards. The role governs change and release processes, maintains customer-facing validation materials, supports compliance-related sales and customer requests, and monitors emerging regulations. The Director also leads the QA/RA consulting team and partners with Engineering, Product, Security, Sales, and company leadership. External representation may include content, conferences, and standards work. Success is measured by avoiding major nonconformities in certification audits and closing findings on time; achieving or maintaining committed certifications, including ISO 26262 by August 2027; publishing validation packages and risk assessments for every platform release; responding reliably to customer compliance inquiries and deal blockers; and delivering high-quality consulting work without quality-related escalations.

Requirements

At least 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 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 Haves

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.

Responsibilities

Own the QMS and support the ISMS, keeping policies, standard operating procedures, and records aligned with company operations, including ISO/IEC 27001 and SOC 2 programs.
Lead AI governance, own AI policies and ISO/IEC 42001 conformity, and establish assurance expectations for validated AI agents.
Lead readiness and execution for certifications and audits covering ISO 13485, IEC 62304, ISO 14971, ISO/IEC 27001, SOC 2, IEC 61508, and ISO 26262, as well as customer audits and supplier assessments.
Define risk-based change and release gates and evidence expectations, and own release-level risk assessments.
Maintain validation packages and the trust center, and support questionnaires, RFPs, and strategic accounts when compliance is a blocker.
Monitor emerging requirements, including EU MDR, the EU Cyber Resilience Act, and 21 CFR Part 11, and translate them into internal and customer guidance.
Lead the QA/RA consulting team by staffing engagements, setting deliverable standards, conducting final reviews, and developing consultants.
Partner with Engineering, Product, Security, Sales, and leadership.
Represent Ketryx externally through content, conferences, and standards work.