QPM Engineer
Core
International Quality Project Manager coordinating global QM projects from concept to mass production for a new critical production line ramp-up.
Role type
Senior IC Quality Project Manager
Builds
New production line ramp-up and mass production handover
Domain
Medical device manufacturing / Quality Management Systems
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Project management, APQP, DFMEA, PFMEA, Control Plan, ISO 13485, Six Sigma, regulatory compliance (FDA CFR 820, MDR), gap analysis, corrective action planning, validation protocols, quality documentation, stakeholder management
Preferred skills
Statistical tools, problem-solving techniques, DFM, continuous improvement
Technologies
IT systems for Quality Management
Responsibilities
Manage project execution across business functions to meet quality and regulatory requirements; monitor project status and implement countermeasures for gaps; lead quality system implementation and APQP deliverables; act as key contact for customer quality and regulatory discussions; present quality performance results to internal and external customers; conduct gap analyses and define corrective actions; drive initiatives to improve production efficiency and KPIs.
Seniority
Senior, hands-on IC
