Quality Assurance Manager
Core
Leads the Quality Operations Organization to ensure high-quality manufacturing, regulatory compliance, and process improvements for structural heart devices.
Role type
Senior Quality Assurance Manager (Manufacturing)
Builds
High-quality medical devices and compliant quality systems for the Structural Heart division
Domain
Medical Devices / Structural Heart / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory compliance management, team leadership, staffing planning, performance management, budget analysis, process improvement, CAPA management, audit support, project management, resource allocation
Preferred skills
Six Sigma Black Belt, ASQ Certified Quality Engineer, Class II or III medical device experience
Technologies
Quality System tools, CAPA systems, audit software
Responsibilities
Direct projects to ensure manufacture of high quality product and facilitate compliance with regulatory requirements; Implement staffing plans and coordinate selection processes; Develop direct reports through training and performance reviews; Monitor daily work operations and provide guidance to staff; Interpret and execute policies affecting work processes; Monitor compliance with company policies and regulations (FDA, BSI, EEO); Contribute to development and monitoring of area budgets; Translate department goals into individual objectives and KPIs; Identify and implement processes to improve department performance; Provide manufacturing support by defining work assignments to address defects and implement improvements; Direct work assignments for quality control auditors; Support new product development by defining projects focused on new products/process development; Own, author, review, approve, and support CAPA activities; Escort internal and external auditors; Implement improvements to Quality Systems and tools by directing personnel to gather data and select new tools; Ensure sustaining support of Quality System and regulatory compliance.
Seniority
Senior, hands-on IC with leadership responsibilities