Head of Quality & Digital Quality
Core
Strategic leadership and continuous improvement of the global Quality Management System (QMS) for Medical Devices, integrating digital solutions and ensuring regulatory compliance across EMEA/LA/AP regions.
Role type
Senior leadership, functional lead for Quality Management Systems & Digital Quality
Builds
Global QMS ecosystem, risk-based audit programs, management reporting, and regulatory compliance frameworks
Domain
Medical Devices, Regulated Industries, Quality Assurance, Digital Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, QMS governance, risk identification and mitigation, audit program management, CAPA management, change management, regulatory inspection support, Computer System Validation (CSV), digital quality system implementation
Preferred skills
Professional membership in quality/regulatory bodies, Qualified Person (QP) experience, ISO 13485 Lead Auditor Certification
Technologies
Audit management tools, CAPA systems, reporting systems
Responsibilities
Provide governance over the Integrated QMS, identify process risks and drive mitigation, establish and lead risk-based audit programs, act as functional lead for the corporate audit team, deliver management reporting on QMS effectiveness
Seniority
Senior, hands-on IC with strategic leadership scope