**FIX TERM CONTRACT** **About Abbott** Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve. **Abbott in Ireland** Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946. **PURPOSE OF THE JOB** The Training Lead is a member of the Quality Team and plays important role in supporting the business in adhering to its quality and regulatory objectives. Additionally, this role is focused on implementing the Training Strategy for IVDR specific activity and for the Abbott Rapid Diagnostics Galway (ARDG) QMS as required. The role is fundamental to supporting the implementation & maintenance of Abbott’s Quality System in alignment with applicable regulations and standards including ISO 13485, FDA 21 CFR 820 etc. **Responsibilities and Duties:** + Carries out duties in compliance with established business policies and procedures. + Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies. + Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. + Responsibility to understand and maintain awareness of the compliance consequences which may occur from the improper performance of specific duties. + Coordinates and implements the Training Strategy for ARDG and for IVDR resources. + Ensures compliance and effective implementation of our Training Procedure within the company’s ISO13485:2016 quality management system. + Manage New Hire Induction, Training Records and Assessments. + Responsible for developing and maintaining role specific training matrix within ARDG as necessary. + Assign relevant training for required employees. + Provides Systems Training to relevant team members. + Coordinates New Hire Induction Training. + Deploys competency-based training across the business where relevant. + The Training Lead oversees the training process following ARDG procedures, reports to management, and ensures compliance during audits. + Participates in audit preparation and audit facing as the SME for training process. + Responsible for tasks associated with the IVDR programme and ARDG as required. + Reporting of training metrics including interrogation of data. + Perform other duties and projects as assigned. **Requirements:** + Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience. + A minimum of 2 years’ experience required. + Experience working in Medical Devices or similar regulatory environment preferred. + An understanding of the training related requirements to satisfy global Quality Policies/Guidelines for training and external regulators. + Excellent attention to detail. + Requires a demonstrated ability to diagnose and solve training gaps and to engage key stakeholders in the implementation. + Ability to project manage and ensure completion of the project required. + Ability to build relationships, promote training, share best practice and solve problems. + Experience in Quality Management Systems preferred. + Excel and Outlook skills required. + Fluent in English, with strong verbal and written communication skills. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com