Quality Engineer

1 month ago

Donegal, Ireland Abbott Full time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 5,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Ireland Diabetes Care Division Donegal

The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system.

Primary Function :

The Quality Engineer (Validation) is responsible for implementing and maintaining the effectiveness of the Quality System.

Major Responsibilities:

Responsible for reviewing, and approving all validation deliverables for Equipment, Facilities, Utilities, Software, Spreadsheets and Analytical validations at site.

Responsible for the development and maintenance of Quality System procedures.

Ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance.

Monitor and maintain the quality and compliance status of associated quality records.

Maintain the quality and compliance status of associated procedures, work instructions and training materials.

Present and communicate status, report metrics, identify trends potential issues, improvement initiatives, as applicable.

Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.

Education and Years Experience:

Relevant third level qualification. Engineering/Manufacturing/Science is preferred.

Minimum 2 years in Engineering/Manufacturing/Scientific.

Must have a minimum of 1-2 years validation experience within the areas of manufacturing or Testing Laboratories with emphasis on software and equipment validations

Must be a self-starter who can prioritize own work

Strong analytical and problem-solving skills

Strong communication (written and oral), presentation skill required

Experience of Manufacturing Execution Systems is desirable

Experience of manufacturing database is desirable

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