Manager, Quality Engineering
Core
Lead quality assurance activities to ensure product quality, process performance, audit readiness, and continuous improvement across site operations.
Role type
Manager, Quality Engineering (Manufacturing)
Builds
Effective quality systems and compliant manufacturing operations
Domain
Regulated manufacturing (Medical Devices/Healthcare)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system compliance, regulatory audit leadership, team management, risk assessment, CAPA management, process improvement, stakeholder partnership
Preferred skills
Strategic quality planning, multi-site quality leadership, Lean/Six Sigma expertise, global quality systems experience
Technologies
FDA regulations, ISO standards, CAPA systems, Quality metrics tools
Responsibilities
Lead the Quality Assurance team providing technical guidance and oversight; Partner with site leadership to ensure products meet customer and regulatory expectations; Drive quality system compliance and audit readiness; Oversee management of nonconforming products and deviations; Monitor and improve quality performance indicators; Support development of local and global Quality Operations strategies
