Quality Systems Engineer

• Quality System compliance to ISO9001, ISO13485 and Medical Devices Directive
• Represent EMEA on global quality initiatives
• Liaise with EMEA manufacturing sites and subcontractors
• Drive and implement Quality System Improvements Perform audits of subcontractors
• Perform internal audits
• Support external audits
• Manage CAPA and Event Investigations for site

• Engineer/Science qualification with minimum of 8 years working within QA/RA in a multi-national Medical Devices environment
• Attention to detail and accuracy - essential
• Ability to work well under deadlines and pressure
• Problem solving skills for developing creative solutions and meeting objectives are required
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
• Excellent analytical ability
• Communication skills
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.