Senior Manager, Quality Operations (Onsite)
Core
Lead quality process execution, issue resolution, performance monitoring, and continuous improvement initiatives to ensure quality systems remain effective, compliant, and aligned with business objectives while supporting product quality and patient safety.
Role type
Senior Manager, Quality Operations
Builds
Quality systems, process excellence activities, and operational strategies for the Emergency Care division
Domain
Medical Devices / Healthcare / Quality Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality systems management, issue investigation, corrective and preventive action (CAPA), regulatory compliance (FDA/ISO), performance monitoring, team leadership, budgeting and forecasting, cross-functional partnership
Preferred skills
Lean, Six Sigma, continuous improvement methodologies, enterprise resource planning (ERP) systems (SAP, Oracle, JD Edwards)
Responsibilities
Lead day-to-day quality system activities and resolve quality issues; Establish and monitor quality performance metrics and reporting processes; Manage product quality, safety, complaint, and corrective action processes; Develop and implement quality process improvements and operational strategies; Partner with QA, R&D, Manufacturing, Supply Chain, Commercial, and Finance teams; Represent quality systems during internal, external, regulatory, and third-party audits; Develop annual budgets, forecasts, resource plans, and departmental objectives; Recruit, develop, coach, and manage team members
Seniority
Senior, hands-on IC with people leadership