Compliance Engineer

Abbott Laboratories•Donegal Township, PA

6d•Onsite

About The Position

Abbott in Ireland has been operating since 1946 and offers a diverse range of healthcare products. The Abbott Diabetes Care division in Donegal Town manufactures FreeStyle blood glucose test strips and FreeStyle Sensors. This role is conditional upon successful completion of a pre-employment medical examination, including drug and alcohol screening. The Compliance Engineer will be responsible for ensuring compliance across various operational areas, managing equipment assets, developing continuous improvement plans, and coordinating projects. This role requires strong communication skills and the ability to work effectively in a fast-paced team environment.

Requirements

Third level qualification in Engineering / Manufacturing / Science disciplines
Excellent communication / interpersonal skills
Enthusiastic and energetic with the ability to integrate quickly into a fast pace team environment

Nice To Haves

4 years experience in a similar environment preferred.

Responsibilities

Complete the Impact assessment and investigation of non-conformances associated with non-conforming products, out of Specifications (OOS), audit findings and customer complaints.
Member of cross functional investigation team to ensure OOS investigations are completed in accordance with procedural requirements.
Support Ops Manufacturing and ensure compliance across all areas for Audit Readiness.
Contribute to the creation and update of Work Instructions and Operation procedures to maintain compliance.
Manage the Equipment Assets on site, maintain and update the Asset Management / Maintenance System.
Support the engineering team in ensuring that facilities, utilities and equipment are maintained to meet the required standards.
Maintain and manage the change control of updating the Asset management / Maintenance system.
Develop Continuous Improvement Plans and activities as related to manufacturing and quality process.
Coordinate and implement process and equipment projects. Identification of opportunities for new technology and driving continuous improvement.
Manage and review the Operation KPI’s, (e.g. NC Closure Rate, Track & Trend, PM’s completed).
Review Change Control Documents and support the approval process of updated documents.
Ensure adherence to 6 S in the Operation areas ensuring the department conducts its business in a manner designed to be protective of human health, safety and the environment.
Maintain strong communication and working relationships with all departments.
Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management.
Complete Tasks as assigned by Lead.