Quality Engineer I
Core
Apply quality principles, analyze records, and conduct inspections to ensure high-quality medical device products for customers.
Role type
Quality Engineer I (Manufacturing)
Builds
Medical device components and systems for vascular disease treatment
Domain
Healthcare / Medical Devices / Vascular
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality principles, inspection, verification, validation, problem identification, data gathering, preliminary analysis, risk evaluation, CAPA resolution
Preferred skills
FDA/ISO regulation knowledge, Statistics knowledge, Quality background
Technologies
FMEA, CAPA
Responsibilities
Apply quality principles and analyze quality records; Conduct inspection, verification, and validation of components; Identify and address recurring product or testing reliability problems; Investigate, conduct tests, gather data, and perform preliminary analysis; Identify and evaluate areas of risk regarding compliance and performance; Resolve production process deviations and non-conformances
Seniority
Junior, hands-on IC