Device History Record Reviewer

Found in: Talent IE C2 - 3 weeks ago

Kilkenny, Ireland Abbott Full time

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

Abbott Ireland

In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has 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

Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.

At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare. 

This is how you can make a difference at Abbott:

The Device History Record Reviewer is responsible for ensuring all product was manufactured and tested in compliance with the current regulatory requirements and that all relevant documentation was appropriately completed prior to batch disposition. Provide support to manufacturing teams, helping to ensure delivery of the highest quality product to the customer.

Determines lot suitability for release by reviewing test results against product specifications.

Assesses the cumulative impact of lot deviations, notes and non-conformances.

Release product by performing the necessary transactions in Systems Applications and Products (SAP)

Supports quality operations, and CAPA teams to identify quarantined lots on SAP.

Audits material and the work of others through the examination, inspection, measurement, or test of raw materials, components, sub-assemblies and documentation.

Gain knowledge of the manufacturing process by becoming familiar with system applications and critical process steps.

Utilize the review of manufacturing documentation and protocols to conduct validation.

Informs personnel of product release issues by providing feedback immediately upon discovering of issues.

Collaborate with internal customers by meeting regularly, responding to requests and explaining procedures.

Minimum Level 6 NFQ qualification or equivalent in a relevant discipline.

Minimum 2 years experience in manufacturing environment.

What we Offer

Attractive compensation package that includes competitive pay, as well as benefits such as

Family health insurance,

Excellent pension scheme

Life assurance

Career Development

Fantastic new facility

Growing business plus access to many more benefits.

Abbott is an equal opportunities employer.

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