environment, Architectural design, Concept generation and Functional analysis Engineering expertise across the engineering lifecycle V-Model from initial concepts, requirements, design, implementation, integration, verification, validation, maintenance and supportability Ability to create and manage interfaces, specifications and certificates, producing boundary views and identifying ownership across the System of Interest (SoI), Wider more »
Experience in medical device industry/Knowledge of ISO13485 & FDA QSR requirements. Knowledge of world class quality techniques and implementation. Good working knowledge of validation, data integrity, statistics, technical drawing and tolerancing. Knowledge of Good Manufacturing Practice, Good Laboratory Practice and Quality Systems Strong attention to detail. Familiarity with appropriate more »
analysis. They are looking for a Quality Engineer who's looking for a fresh challenge and who can bring experience in product and process validation, who's not afraid of a bit of legwork, and who's up for the challenge of introducing new products to the system and keeping more »
/VSM/Kaizen). Minimum of HNC level qualification in mechanical, electronic, industrial or manufacturing engineering, or similar. Experience in process and product validation (sterile packaging according to ISO 11607 would be advantageous). Understanding of a quality management system (ISO13485/FDA) and medical device manufacturing advantageous. Very more »