Associate Manager, Quality Assurance
Core
Lead a Quality Operations team to drive quality excellence, compliance, and risk prevention across manufacturing and business functions.
Role type
Senior IC Quality Assurance Manager
Builds
Quality systems, compliance processes, and operational effectiveness
Domain
Medical device manufacturing / Regulatory compliance
Required skills
Regulatory requirements knowledge, Quality tools (SPC, FMEA, Root Cause Analysis, Six Sigma), Team leadership, Audit management, CAPA oversight, Performance metrics analysis
Preferred skills
FDA-regulated environment experience, Business Management/MBA, Organizational change management
Technologies
SPC, FMEA, Poka-Yoke
Responsibilities
Lead and develop a Quality Engineering team, Ensure products and processes comply with quality standards and regulations, Partner with site leaders to establish and improve quality systems, Support internal and external audits, Oversee investigations and nonconformances, Monitor quality performance metrics
Seniority
Senior, hands-on IC