Description
The Quality Engineer supports the design and implementation of testing, evaluation, quality systems, and process-engineering policies for medical devices. The role maintains FDA and ISO 13485 compliance, supports audits and customer inquiries, leads IQ/OQ/PQ and continuous-improvement projects, manages CAPA and supplier qualification activities, and provides measurement-system, process-capability, GD&T, and design-for-manufacturing support. It is an on-site position in Houston, Pennsylvania and requires a bachelor's degree in engineering or a related field, 2–5 years of quality experience in a regulated industry, and proficiency with data-analysis software.
