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Salary: USD 150,000 - 185,000 / annual
Ketryx is a compliance software platform for regulated medical device and life sciences companies. The Director of Quality owns the company's Quality Management System (QMS), Information Security Management System (ISMS), AI governance program, and certification portfolio. This is a leadership role responsible for keeping processes effective, scalable, and audit-ready while enabling the business to ship products and serve enterprise customers efficiently. The Director serves as an internal reference user of Ketryx's own platform and as a public voice on quality and regulatory practice.
Key responsibilities include:
- Own and maintain the QMS and support the ISMS, ensuring policies, SOPs, and records align with operations and compliance requirements including ISO/IEC 27001 and SOC 2 programs.
- Lead AI governance initiatives, owning AI policies and ISO/IEC 42001 conformity, and setting assurance expectations for validated AI agents.
- Lead readiness and execution for multiple certifications and standards: ISO 13485, IEC 62304, ISO 14971, ISO/IEC 27001, SOC 2, IEC 61508, and ISO 26262. Also manage customer audits and supplier assessments.
- Define risk-based gates and evidence expectations for change and release governance, and own release-level risk assessments.
- Maintain validation packages and trust center resources; support customer compliance questionnaires, RFPs, and strategic accounts where compliance is a deal blocker.
- Monitor emerging regulatory 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, staffing engagements, setting deliverable standards, providing final review, and developing team members.
- Partner across Engineering, Product, Security, Sales, and leadership; represent Ketryx externally through content, conferences, and standards work.
Success is measured by zero major nonconformities in certification audits with timely closure, achievement and maintenance of all committed certifications (including ISO 26262 by August 2027), published validation packages and risk assessments for every platform release, fast and reliable responses to customer compliance inquiries, and high-quality consulting deliverables with zero escalations.
Requirements:
- 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; 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
