Sr QMSR Manager
Core
Develops, implements, and maintains quality systems to ensure product conformity with government and company standards, specifically within medical device or pharmaceutical manufacturing.
Role type
Senior Manager, Quality Management System (QMS)
Builds
Quality management systems, compliance frameworks, and regulatory response strategies
Domain
Medical Device / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality systems management, regulatory compliance (FDA, ISO 13485), CAPA management, budget management, team leadership, metrics analysis, training program design
Preferred skills
CQE/CQA/CQM certification, SAP experience, Crystal reporting, project management, experience managing multiple departments
Technologies
SAP, Crystal reporting, Microsoft Office, database software
Responsibilities
Manage tactical execution of quality objectives, oversee development of standards and procedures, analyze quality data trends, ensure regulatory compliance, manage department budget and staffing, provide technical guidance on quality processes
Seniority
Senior, hands-on IC with management responsibilities