Senior Staff QE
Core
Define and execute validation strategies for medical devices, ensuring regulatory compliance and establishing industry best practices across multiple sites.
Role type
Senior Staff Quality Engineer (Validation)
Builds
Validated/Qualified systems and processes for medical devices
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation strategy definition, regulatory interpretation, validation documentation review, audit representation, team mentoring, change control evaluation, site validation listing management, validation procedure development
Preferred skills
Subject matter expertise in multiple validation specialties, guidance on corporate/divisional/local procedures
Technologies
Validation protocols, qualification documentation, audit tools
Responsibilities
Participate in defining validation strategy based on regulatory requirements; review and approve validation/qualification documentation; represent validation at internal and external audits; mentor Graduate Validation Engineers; establish and drive validation standards across the organization
Seniority
Senior Staff, hands-on IC with strategic guidance
