About Abbott Ireland
Abbott employs approximately 6,000 people across nine 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. We have been making a difference in the lives of Irish people since 1946.
Diabetes Care Kilkenny
We are opening a new manufacturing facility in Kilkenny in 2024, which will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies.
The FreeStyle Libre 3 system automatically delivers real-time glucose readings, providing unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live their best lives.
Your Role
In this role, you will be responsible for creating and implementing the Abbott Division validation program. You will create and maintain validation documentation for new and existing systems and processes subject to design control.
You will ensure that validation activities are implemented for systems and processes used to manufacture, control, and store intermediates and finished products to requirements and standards listed in the current Quality Systems Manual.
Responsibilities
* Develop and maintain Quality System procedures.
* Evaluate the site's ability to deliver safe and effective products that meet customer needs while maintaining compliance.
* Maintain the quality and compliance status of associated quality records, procedures, work instructions, and training materials.
* Present and communicate status, report metrics, identify trends, potential issues, improvement initiatives, as applicable.
* Review and approve validation documentation in accordance with divisional policies.
* Have a basic understanding of design controls and design transfer.
Requirements
* A relevant third-level qualification in Engineering, Manufacturing, or Science is preferred.
* A minimum of 4 years of experience in the Engineering, Manufacturing, or Scientific field.
* A minimum of 4 years of working knowledge of process, equipment, facilities, and/or software validation within Quality or Engineering departments.
What We Offer
* An attractive compensation package, including competitive pay and benefits such as family health insurance, excellent pension scheme, life assurance, career development, and access to many more benefits.