Irvine, California30+ days ago
Perform process development, validation, and verification work, including applying knowledge of Factory Acceptance Test (FAT), Process Validation Plans, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), software validation, test method validation, Gage Repeatability and Reproducibility (R&R), and the U.S. Food and Drug Administration (FDA) Quality System Regulation (QSR) and Current Good Manufacturing Practice (cGMP) regulations. Senior Process Engineer (Balt USA LLC, Irvine, CA): On behalf of a surgical and medical instrument manufacturing company with an emphasis on R&D, marketing, quality, sales, clinical affairs, and regulatory compliance, is responsible for supporting and continuously improving upon current manufacturing processes for the manufacture of neurovascular medical devices that save patient lives.