Artivion, Inc. Benefits Overview

Lead quality engineering for new product development and transfer to manufacturing. Develop and approve validation, qualification, and test methods; troubleshoot inspection and laboratory equipment; perform audits, CAPA investigations, risk management (FMEA), and sampling plans; ensure regulatory and quality system compliance across manufacturing. Serve as technical resource for inspection, metrology, and product verification and collaborate with cross-functional teams to resolve quality issues and support continuous improvement.

Perform cleanroom sewing and assembly of heart valve components, inspect parts and finished goods with a microscope, maintain production and inspection records, monitor and clean the cleanroom, batch components, follow GMP/ISO/FDA practices, meet quality and production targets, and work scheduled hours including overtime and Saturdays.

Maintain and operate the Quality Management System for medical device manufacturing. Support CAPA, internal/external audits, change control, nonconformance monitoring, KPI reporting, and continuous improvement activities.