Quality Engineer I (On-Site - Austin, TX)

Role: Quality Engineer I supporting new product development and existing product line manufacturing within a medical device company specializing in cardiac and vascular devices. Responsibilities: provide technical quality support, analyze non-conformances, execute and analyze validations for equipment, processes, and software, and assist in development and documentation of qualifications/validations to ensure product safety, effectiveness, and compliance. Collaborate with R&D and manufacturing to support product launches, risk management including FMEAs, review test methods, and investigate non-conformances and customer complaints. Requirements: Bachelor’s degree in engineering or equivalent; 0-2 years’ experience, preferably in FDA-regulated biomedical or medical device industry; knowledge of GMP, Quality System Regulations, and ISO standards. HighValue: medical devices, cardiac/vascular, new product development, validations, risk management, FDA compliance, Quality Engineering. WorkSetup: not specified, likely on-site or hybrid.