At Abbott, you play a vital role in helping people live more fully at all stages of their lives. We are a global healthcare leader with a diverse portfolio of life-changing technologies spanning diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 employees have a daily impact on the lives of people in over 160 countries.
About Us
We employ approximately 6,000 people across ten sites in Ireland, including six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, Sligo, and a third-party manufacturing management operation in Sligo. Additionally, we have commercial, support operations, and shared services in Dublin and Galway. Our presence in Ireland dates back to 1946.
Diabetes Care Kilkenny
Our new manufacturing facility in Kilkenny caters to the growing demand for our global Diabetes Care products. This state-of-the-art facility will serve as a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies that empower individuals with diabetes to live their best lives.
This is how you can make a difference at Abbott
As a CAPA Engineer, you facilitate and execute the CAPA process, supporting continuous improvement and effective maintenance of the Quality Management System. You ensure the use of appropriate risk management tools to prioritise activities.
Key Responsibilities
1. Participate in CAPA projects, ensuring compliance and quality of records.
2. Collaborate with cross-functional teams using methodologies like Six Sigma root cause analysis/problem solving skills.
3. Independently investigate, gather data, and perform preliminary analysis.
4. Process requests, assigning owners and providing timely responses and approvals aligned with quality goals.
5. Identify trends, potential issues, and improvement initiatives.
6. Ensure on-time completion of Quality Assurance engineering deliverables.
7. Support training programs for CAPA.
8. Identify projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.
9. Support Operations to make Quality/Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging.
10. Provide subject matter expertise during audits and inspections.
Qualifications and Experience
11. Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
12. Min of 4 years experience in Engineering/Manufacturing/Scientific environment.
13. Previous CAPA and/or quality assurance/engineering experience.
14. Ability to demonstrate the use of quality tools/methodologies.
15. Prior medical device experience preferred.
16. Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
17. Good communication and interpersonal skills.
18. Previous project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
19. Advanced computer skills, including statistical/data analysis and report writing skills.
We Offer
An attractive compensation package, including competitive pay and benefits such as:
20. Family health insurance
21. Excellent pension scheme
22. Life assurance
23. Career Development
24. Fantastic new facility
25. Growing business plus access to many more benefits.