Quality Test Engineer
Core
Investigate root causes of customer complaints related to product design, manufacturing, and testing for medical device capital equipment.
Role type
Quality Test Engineer
Builds
Corrective and preventive actions (CAPA) to resolve manufacturing and supplier issues
Domain
Medical devices / Manufacturing quality
Deliverable
client delivery
Required skills
root-cause analysis, data analysis, engineering fundamentals, regulatory knowledge, CAPA management, audit support, problem-solving
Preferred skills
Six Sigma, FMEA, Fault Tree Analysis, Human Factors, risk management, ISO 13485, FDA QSR, ISO 14971, Minitab, QI Macros, CAPA/NCR audit software
Technologies
Minitab, QI Macros, CAPA software, NCR systems
Responsibilities
Investigate customer complaints, analyze data to identify manufacturing issues, support internal and external audits, participate in CAPA trending meetings, communicate quality issues to management
Seniority
Mid-level, hands-on IC