QPM Engineer
Core
Coordinate global Quality Management projects from concept to mass production, ensuring compliance with regulatory requirements and reliability standards for a new critical production line.
Role type
Senior Quality Project Manager
Builds
New production lines and critical manufacturing processes
Domain
Medical device manufacturing / Quality Engineering
Required skills
Project management, Quality methodologies (APQP, DFMEA, PFMEA, Control Plan), Regulatory compliance (FDA CFR 820, MDR, ISO 13485), Gap analysis, Corrective action implementation, Stakeholder management, Data analysis
Preferred skills
Six Sigma, Statistical tools, IT system implementation for QM, Training and knowledge transfer
Technologies
APQP, DFMEA, PFMEA, Control Plan, FDA CFR 820, MDR, ISO 13485
Responsibilities
Manage project execution across business functions to meet quality and regulatory requirements; Monitor project status and implement countermeasures for quality gaps; Lead quality system implementation and APQP deliverables; Act as key point of contact for customer quality and regulatory discussions; Present quality performance results to internal and external stakeholders.
Seniority
Senior, hands-on IC
