Abbott Quality Professional - Design Control in Longford, Ireland
Abbott in Ireland
In Ireland, Abbott employs almost 3,000 people across 11 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third party manufacturing management operation in Sligo. It has commercial and support operations in Dublin and shared services in Dublin and Westport. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott has been operating in Ireland since 1946.
Abbott Diagnostics Division – Longford (ADDLF)
Abbott established the first diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents. In 2004, Abbott Diagnostics operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004. Manufacturing commenced in March of the following year and the first product (Architect TSH) was launched in December of 2005.
The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid and cardiovascular diseases.
We currently have a vacancy for a Quality Professional - Design Control and this role will involve the following:
General Area: Contributes to defining and timely achievement of overall project goals. Provides compliant solutions to a variety of problems of moderate scope and complexity. Interacts constructively with employees, managers and cross-functional peers. May lead a project with a limited scope, but usually a contributor on broader projects. Provides guidance to other Professionals and Technicians. Scope typically limited to one specific QA function.
Quality System Compliance: Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
Risk Management: Applies basic to moderate Risk Management principles to work.
Problem Solving: Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions.
Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight. Decisions may have short and long term impact.
Depending on Functional Area
Risk Management: Participates in the development or modification of Risk management files.
Complaint Evaluation: Investigates complex complaints with management oversight. Provides compliant solutions to a variety of complex problems
Ensures compliant documentation related to area of responsibility.
Design Control / Documentation & Change Control: Identifies areas for process improvement.Provides supporting information for change including reasons and justifications.
Quality Engineer: Coordinates quality decisions between different quality and engineering groups.Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs). Team member helping and interfacing with suppliers to deliver product meeting our quality requirements.
Education and Years Experience:
Apprenticeship or relevant third level qualification in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
Demonstrates understanding of how their function supports the business.
Demonstrates technical and business competencies that drive results and continuous improvement.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com