Quality Assurance Manager (Medical Devices) - (Chicago, IL)

Essential duties and responsibilities Ensure Quality Systems activities are implemented and maintained to satisfy FDA GMP/QSR, ISO 13485 and applicable worldwide regulatory qualifications. Identify and lead the implementation of continuous improvement opportunities (process and/or quality-related) focused on exceeding customer needs. Participate, as required, in the corporate Internal & Supplier audit program. Supervise that CAPA and Internal Audits processes are effectively working at the Spanish site. Be involved, as needed, in any Corporate or outside agency inspections relating to Quality Systems and act as a Quality Management Representative for the Spanish site. Identi ...