Description
Antylia Scientific is hiring a Quality Assurance Engineer in Buffalo, New York to support and maintain the Quality Management System for medical devices in compliance with FDA, ISO 13485, CMDR, and TGA requirements. The role partners with R&D, Manufacturing, and Regulatory Affairs on design control, CAPA, risk management, validation, audits, change controls, supplier quality, customer complaints, quality data analysis, and continuous improvement. Candidates should have a bachelor’s degree in engineering, life sciences, or a related field, 3–5+ years of GMP-quality experience, and ASQ CQE or similar certification; experience with regulatory submissions, eQMS systems, and ISO 14971 risk management is preferred. The salary range is $70,000–$85,000, with medical, dental, and vision insurance and other benefits.
