Design Quality Professional (m/w/d), befristet bis 31.03.2029
Core
Independent quality monitoring of product development activities and driving continuous improvement of risk management in global MedTech development sites.
Role type
Senior Design Quality Professional (MedTech)
Builds
Medical devices and software ensuring regulatory compliance throughout the product lifecycle
Domain
MedTech / Medical Devices / Regulatory Quality
Required skills
ISO 14971 risk management, ISO 13485, EU MDR, FDA requirements, MDSAP, hazard analysis, FMEA, post-market surveillance, CAPA management, regulatory audits
Preferred skills
Organizational change management, process harmonization, cross-functional team leadership
Technologies
ISO 14971, ISO 13485, MDR, FDA QMSR, MDSAP
Responsibilities
Monitor design quality during development and lifecycle changes; Lead product risk management activities including hazard analysis and FMEA; Consult cross-functional teams on risk-based decisions; Lead investigations, CAPAs, and complaint evaluations; Support regulatory inspections and audits; Drive initiatives to improve risk management and inspection readiness
Seniority
Senior, hands-on IC