Advanced Quality Assurance Specialist

Role: Advanced Quality Assurance Specialist supporting Asuragen’s Quality Management System in compliance with international standards (ISO 13485, FDA QSR, MDSAP, IVDR). Responsibilities: ensure regulatory compliance, support QA activities across systems (Document Control, NCR, CAPA, audits), manage validation and calibration reviews, support regulatory and client audits, generate quality metrics, and contribute to QA departmental goals. Requirements: Bachelor’s/Master’s in a related field; 4-6 years in a regulated manufacturing environment; strong knowledge of QA principles, cGMP, ISO 13485, MDSAP, IVDR, FDA QSR; proficiency in MS Office and database tools; detail-oriented, capable of working under tight deadlines, and effective communicator. Preferred: familiarity with statistical tools, dispute resolution skills, team-oriented attitude, and knowledge of regulatory standards. HighValue: regulated manufacturing, ISO 13485, FDA QSR, MDSAP, IVDR, quality system management, audit facilitation, cGMP, and validation processes. WorkSetup: not specified; likely on-site/office-based with potential for hybrid depending on operational needs.