Senior Quality Engineer - Cardiac Diagnostics (CDx)
Core
Lead quality engineering initiatives to ensure product quality, compliance, and continuous improvement for cardiac diagnostics devices.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Cardiac diagnostics products and services
Domain
Medical Devices / Cardiac Diagnostics
Required skills
CAPA management, root cause analysis, regulatory compliance (ISO 13485, MDR), process validation, defect analysis, cross-functional leadership, NCEP coordination
Preferred skills
Master's degree in engineering, experience with regulatory submissions to notified bodies, mentorship
Technologies
ISO 13485, Medical Device Regulation (MDR), NCEP, CAPA systems
Responsibilities
Lead Corrective and Preventive Actions (CAPA) processes, evaluate system compliance against regulations, investigate and resolve quality issues, analyze process defect data, support regulatory submissions, mentor team members on quality practices
Seniority
Senior, hands-on IC