Patrick Sauder

Corporate Quality Management System Design & Development, Risk management, Production, Purchasing, Logistics, CAPA, Customer Complaints, Production, Purchasing, Logistics, Audits and Quality Management Responsibility

Quality Management System (Switzerland & Toulouse), Quality Management Responsibility, Internal and supplier audit, CAPA Management, Complaint Management, Design & Development Life Cycle Process, Design Control, Risk Management (AFMEA, DFMEA, PFMEA), Design Review, V&V, Regulatory Planning, Technical File, CE declarations, FDA submissions, Production and Process Control (PFMEA, DMR, DHR), Inspection Planning, QMS Training

Design & Development of various medical devices (software and hardware) designed in multiple engineering sites and external contractors (USA, UK, Finland, Switzerland), Managing international project development teams, product registration e.g. FDA, EU, Japan etc., Design Transfer of the product to manufacturing, Verification & Validation management, Technical Publication (IFU)

Quality Management System (Switzerland & UK), Quality Management Responsibility, Design Control, CAPA/local Complaint Management, Production and Process Control, Internal and supplier audit, QMS Training, Production outsourcing, supplier quality agreements, FDA submissions strategies, preparation of the FDA 510(k) submissions, CE Declaration

Project Management, Sales Support, Production, IT Management

Installation and maintenance of radio therapy medical linear accelerators in Europe