Teams at Bio-Techne

Support and maintain the Quality Management System to ensure compliance with ISO 13485, FDA QSR, MDSAP, IVDR/IVDD and cGMP. Provide QA support to projects, manage document control, training, NCR/CAPA, complaints, audits and supplier management. Conduct internal/external audits, review validations and equipment calibrations, support regulatory/client audits, and generate quality metrics.