Quality Assurance Manager
Current· Leading a team of ten employees, including inspectors, technologists, engineers and QA specialists· Implementation of MDSAP (USA, Canada, Japan, Australia), ISO13485:2016, EU MDD/MDR· Internal/external CAPA, NCR and TD Management· Internal Audit Management· Software, equipment and process validation· Continuous Improvement of processes, including automation projects (robotics, force testing, visionsystems), each project resulting in a minimum of 20% efficiency gains· Supplier Management (plastic and silicone molding)· Certification, Notified Body, Customer and Regulatory Audits· Budgeting