Associate Director - Digital Solutions Quality Lead
Core
Define and advance the Quality function's digital, data, and AI strategy to improve performance, strengthen compliance, and reduce operational risk within a global medical technology company.
Role type
Senior individual contributor (Associate Director) leading digital solutions and AI strategy for Quality
Builds
End-to-end solution vision for core Quality platforms (e.g., eQMS) and Quality data/analytics capabilities
Domain
Medical Technology / Healthcare Quality / Regulated Environments
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Digital and technology solution leadership in regulated environments, Quality systems and compliance expertise, AI and automation deployment at scale, stakeholder influence without direct authority, enterprise architecture and data strategy, platform modernization and integration
Preferred skills
Experience with eQMS solutions (Trackwise, MasterControl), enterprise data platforms (SAP, Power BI, Databricks), Agile/Hybrid delivery models, AI governance and validation approaches
Technologies
eQMS, Trackwise, MasterControl, SAP, Power BI, Databricks, integration platforms
Responsibilities
Co-create digital, data, and AI strategy aligned to enterprise architecture; Define future-state capability models and outcome-based roadmaps; Identify and scale high-value use cases across Quality processes; Own end-to-end solution vision for Quality platforms; Partner with digital teams to leverage data assets; Provide platform and product direction for roadmaps and lifecycle management; Ensure solutions are scalable, interoperable, and audit-ready; Drive adoption of Quality data models and insights; Champion advanced analytics and responsible AI for regulated use cases; Represent Quality priorities in governance forums; Support audits and improve control/validation approaches for AI/automation
Seniority
Senior, hands-on IC with strategic oversight