At Abbott, you will play a crucial role in helping people live more fully at all stages of their lives. As a global healthcare leader, our portfolio spans the spectrum of healthcare with leading businesses and products in diagnostics, medical devices, nutritional products, and branded generic medicines.
About Abbott Ireland
We employ around 6,000 people across ten sites in Ireland. Our manufacturing facilities are located in Clonmel, Cootehill, Donegal, Longford, and Sligo, with commercial, support operations, and shared services in Dublin and Galway.
Diabetes Care Kilkenny
Our new manufacturing facility in Kilkenny reflects growing demand for Abbott's global Diabetes Care products. This centre will be home to world-class engineering, quality, medical device manufacturing, and other science-based professionals producing life-changing technologies.
Job Title: CAPA Engineer
You will facilitate and execute the CAPA process, supporting continuous improvement and effective maintenance of the QMS. Ensure the use of appropriate risk management tools to prioritise activities.
Key Responsibilities:
* Participate in completing CAPA projects ensuring compliance and quality of records.
* Collaborate with cross-functional teams using methodologies like Six Sigma root cause analysis/problem solving skills.
* Investigate, gather data, and perform preliminary analysis independently.
* Process requests, ensure owners are assigned, and provide timely responses and approvals in alignment with quality goals.
* Identify trends, potential issues, and improvement initiatives.
* Ensure on-time completion of Quality Assurance engineering deliverables.
* Support the team in delivering and overseeing CAPA training programs.
* Identify projects enhancing and promoting the effectiveness and efficiency of the quality system and product quality.
* Support Operations making Quality/Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging.
* Provide support and subject matter expertise during audits and inspections.
Qualification and Experience:
* Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
* Min of 4 years experience in Engineering/Manufacturing/Scientific environment.
* Previous CAPA and/or quality assurance/engineering experience.
* Ability to demonstrate the use of quality tools/methodologies.
* Prior medical device experience preferred.
* Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
* Good communication and interpersonal skills.
* Previous project management and leadership skills including leading multi-departmental project teams and resolving quality-related issues.
* Advanced computer skills including statistical/data analysis and report writing skills.
What We Offer:
An attractive compensation package includes competitive pay, benefits such as family health insurance, excellent pension scheme, life assurance, career development, fantastic new facility, and growing business access to many more benefits.