Overview The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Facilities, IT, Regulatory, Analytical Lab, Research and Development, New Product Introduction and Engineering Sustaining and Post Market teams. This includes, but is not limited to, providing support to design and process validation, change requests, nonconforming product issues, Corrective and Preventive Action program, risk management, trending analysis, audit support, microbiology and sterilisation review and associated Quality System Documentation. Responsibilities Understand and review Validation documentation, Change Requests, Design and Process FMEA's, Software Validation, Microbiological and Sterilisation assessments and Critical System Work Orders. Provide Quality Engineering support to the Research and Development, New Product Introduction (NPI) and Sustaining Engineering departments up to and including transfer to Production, understanding Design Assurance ac...