Quality Assurance Specialist IVD Medical Device

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Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Quality Assurance Specialist is within our Toxicology business unit located at Abingdon, U.K. In this role, you will ensure we meet the requirements of our regulatory and compliance standard committments within the medical device & IVD industry. The position of Quality Assurance Specialist is within our Toxicology Business Unit located at Abingdon, UK. This position is responsible for delivering Quality Management System changes to ensure the business is ready for the new IVD and Medical Device Regulations. This candidate will be coordinating with cross-functional teams, including but not limited to , BU, Division and Corporate AQR, Marketing, Operations, R&D and Supply Chain to ensure that all deliverables are completed correctly and delivered on time. This job description will be reviewed periodically and is subject to change by management. RESPONSIBILITIES : * Develop necessary project plans and manage reporting on project progress and achievement of key milestones. * Oversee project to make necessary updates to Quality System requirements across all functional areas to align to new requirements in the new regulations. * Draft policies and SOPs tailored to ATOX business as necessary and drive to make live in the system. * Develop training plans and participate in training activities. * Support the QARA team in routine activities. * Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. * Perform other duties & projects as assigned.