Director of Quality

The role

The Director of Quality owns the Quality Management System, Information Security Management System, AI governance program, and certification portfolio. This leader maintains effective, scalable, and audit-ready processes while acting as an internal user of the Ketryx platform.

What you will do

• Own the QMS and support the ISMS
• Lead AI governance
• Run audits and certifications
• Govern change and release
• Enable customers and deals
• Track regulation
• Lead the QA/RA consulting team
• Partner across the company

Required qualifications

• 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

Benefits

• Competitive compensation
• Generous stock options possible
• Work in an exciting field with a positive impact on the world
• Opportunity to learn and grow as part of a global team
• Generous PTO for full-time

About the company

Ketryx is saving and improving lives by making medical software safe and reliable. They empower software teams building medical applications to create safe, secure, and compliant products.