Director of Quality
Core
Own the Quality Management System (QMS), Information Security Management System (ISMS), and AI governance program for a compliance software company serving regulated industries.
Role type
Director of Quality (Strategic Leadership & Operations)
Builds
Compliance software platform, QMS, ISMS, AI governance frameworks, and certification portfolios.
Domain
MedTech, BioPharma, Life Sciences, Regulatory Compliance, Information Security
Required skills
Quality Management Systems (QMS), Information Security Management Systems (ISMS), AI governance, audit leadership, risk-based quality practices, change and release governance, regulatory tracking, team leadership
Preferred skills
ISO 13485, IEC 62304, ISO 14971, ISO/IEC 27001, SOC 2, IEC 61508, ISO 26262, ISO/IEC 42001, functional safety tool qualification, customer validation support
Technologies
ISO/IEC 27001, SOC 2, ISO 13485, IEC 62304, ISO 14971, ISO/IEC 42001, IEC 61508, ISO 26262
Responsibilities
Own and maintain QMS and ISMS policies and procedures; lead AI governance and ISO/IEC 42001 conformity; run audits and certifications for multiple standards; govern change and release processes; enable customers and deals with validation packages; track emerging regulations; lead the QA/RA consulting team; partner across Engineering, Product, Security, and Sales.
Seniority
Director, strategic leadership with hands-on operational oversight
