Quality Validation Engineer
Join Abbott as a Quality Validation Engineer and apply your expertise to ensure the highest standards of product quality across diagnostics, medical devices and nutrition products.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans diagnostics, medical devices, nutritionals and branded generic medicines. We employ 114,000 colleagues who serve people in more than 160 countries.
About Abbott in Ireland
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products, including diagnostics, diabetes care, medical devices and nutritional products. We currently employ about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
Main Purpose of the Role
In this role you will be responsible for implementing the Abbott Division validation programme, creating and maintaining validation documentation for new and existing systems and processes subject to design/control change. You will also ensure that validation activities are implemented for components, systems and processes used to manufacture, control and store intermediates (sub‑assemblies) and finished products to the requirements and standards outlined in the current Quality Systems Manual.
Main Responsibilities
* The development and maintenance of Quality System procedures.
* Investigates/troubleshoots validation problems for components, equipment and/or performance processes; monitors and maintains the quality and compliance status of associated quality records.
* Writes, reviews, approves and/or executes documentation for new and existing validation procedures and technical reports related to components, equipment, facilities/utilities, products and/or processes.
* Assists with establishing corporate validation policies and maintaining the quality and compliance status of associated procedures, work instructions and training materials.
* Represents and communicates status, report metrics, identifies trends and potential issues, and initiates improvement initiatives as applicable.
* Maintains basic understanding of design controls and design transfer.
* May be responsible for creating, updating or participating in risk analyses and FMEAs.
* May be responsible for change assessment to ensure product quality and compliance.
Qualifications & Experience
* Relevant NFQ Level 7 Qualification in Engineering/Manufacturing/Science (preferred).
* Minimum 2–3 years of experience in the Engineering/Manufacturing/Scientific field with working knowledge of process, equipment, facilities and/or software validation within Quality or Engineering departments.
* Experience in a 21CFR820 and/or ISO13485 regulated industry (pharmaceutical validations considered a plus).
Abbott is an equal opportunities employer.
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