Sr. Quality Engineer, Failure Analysis
Core
Lead failure analysis investigations on returned medical devices and manufacturing nonconformances to identify root causes and validate failure mechanisms.
Role type
Senior IC Quality Engineer (Failure Analysis)
Builds
Corrective and preventive actions (CAPA) and reliability improvements for medical devices
Domain
Medical Technology / Regulatory Compliance
Required skills
Root cause analysis (8D, 5-Why, Fishbone, FMEA), Microscopy (SEM/EDX), FTIR, DPA, X-ray, Statistical analysis, FDA 21 CFR Part 820, ISO 13485, MDR
Preferred skills
Six-Sigma Black Belt, ASQ CQE/CRE, Master's degree in Engineering
Technologies
SEM, EDX, FTIR, DPA, X-ray, Statistical analysis software
Responsibilities
Conduct failure analysis on returned products and complaints, Develop investigation plans to identify failure mechanisms, Author technical reports on findings and recommendations, Partner with cross-functional teams to implement CAPA, Support reliability testing and design verification, Present technical findings at management reviews
Seniority
Senior, hands-on IC
