Site Quality Manager
Core
Lead manufacturing quality activities and systems for an injection molding site, driving continuous improvement and ensuring regulatory compliance.
Role type
Site Quality Manager (Manufacturing)
Builds
Quality processes, systems, and compliance frameworks for injection molding operations.
Domain
Manufacturing / Medical Device / Injection Molding
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) maintenance, ISO 13485 and FDA 21 CFR Part 820/QMSR compliance, root-cause analysis, CAPA management, nonconformance management, team recruitment and development, strategic planning, cost management, risk management, inspection readiness.
Preferred skills
Injection molding experience, ISO certification implementation and auditing experience.
Technologies
ISO 13485, FDA 21 CFR Part 820/QMSR
Responsibilities
Recruit and coach Quality Engineers; define and implement Quality strategy; manage departmental costs and forecasts; maintain QMS and ensure regulatory compliance; lead root-cause investigations and CAPA; act as primary contact for customer and regulatory inspections; oversee nonconformance and risk management processes.
Seniority
Manager, supervisory role