FIX TERM CONTRACT
About Abbott
Abbott is a global healthcare leader, 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 -- creating 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 an important role in supporting the business in adhering to its quality and regulatory objectives. This role focuses on implementing the Training Strategy for IVDR specific activity and for the Abbott Rapid Diagnostics Galway (ARDG) QMS as required. It 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
1. Carries out duties in compliance with established business policies and procedures.
2. Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
3. Exhibits professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
4. Maintains awareness of compliance consequences which may occur from the improper performance of specific duties.
5. Coordinates and implements the Training Strategy for ARDG and for IVDR resources.
6. Ensures compliance and effective implementation of our Training Procedure within the company’s ISO13485:2016 quality management system.
7. Manages New Hire Induction, Training Records, and Assessments.
8. Develops and maintains role-specific training matrix within ARDG as necessary.
9. Assigns relevant training for required employees.
10. Provides Systems Training to relevant team members.
11. Coordinates New Hire Induction Training.
12. Deploys competency-based training across the business where relevant.
13. Oversees the training process following ARDG procedures, reports to management, and ensures compliance during audits.
14. Participates in audit preparation and audit facing as the SME for training process.
15. Responsible for tasks associated with the IVDR programme and ARDG as required.
16. Reports training metrics including interrogation of data.
17. Performs other duties and projects as assigned.
Requirements
1. Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
2. A minimum of 2 years’ experience required.
3. Experience working in Medical Devices or similar regulatory environment preferred.
4. Understanding of the training related requirements to satisfy global Quality Policies/Guidelines for training and external regulators.
5. Excellent attention to detail.
6. Demonstrated ability to diagnose and solve training gaps and to engage key stakeholders in the implementation.
7. Ability to project manage and ensure completion of the project required.
8. Ability to build relationships, promote training, share best practices, and solve problems.
9. Experience in Quality Management Systems preferred.
10. Excel and Outlook skills required.
11. Fluent in English, with strong verbal and written communication skills.
#J-18808-Ljbffr