Avanir Pharmaceuticals - State College, PA
posted 24 days ago
The Director, Global Product Quality Assurance, Digital Products Development at Otsuka Precision Health (OPH) is responsible for overseeing and ensuring compliance with manufacturing and development regulations for digital devices and other products. This role involves developing and maintaining the Quality Management System for medical device hardware and Software as a Medical Device (SaMD), leading quality assurance activities, and collaborating with various teams to integrate quality into product development. The position also includes supporting regulatory submissions and engagement with agencies like the FDA, while monitoring quality metrics and driving continuous improvement.