Quality Assurance Analyst II

Summary

Quality Assurance Analyst II will process change orders and manage training in an electronic quality management system, ensuring compliance with work instructions and coordinating with cross-functional engineering teams. The role involves document control, record organization, logbook management, NCMR/CAPA investigation, and supplier management in a regulated medical device environment. The candidate must demonstrate strong attention to detail, analytical problem-solving, and ability to communicate with multiple departments in a fast-paced setting. A bachelor's degree preferred with minimum 3 years in medical device/biotech quality document control in an FDA or ISO-regulated industry.