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 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 6,000 people across ten 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 Diagnostic Division Sligo Abbott Diagnostic's is a global leader of in vitro diagnostics with approximately 70,000 institutional customers in more than 100 countries.
Our diagnostic products offer a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.
Abbott's diagnostic products offer customers automation, convenience, cost-effectiveness and flexibility.
Abbott has helped transform the practice of medical diagnosis from an art to a science, helping to create the modern diagnostics industry through the company's commitment to improving patient care and lowering overall costs.
The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements
Primary function The Quality Professional will conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business. Major Duties and Responsibilities 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.EHS: Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager.
Ensure Environmental procedures e.g.
recycling, waste minimization are adhered to and improvements made where possible.Risk Management: Participates in the development or modification of Risk management files.Design Control / Documentation & Change Control: Assist initiators of change control documentation, including change plans, design plans and change requests (as required) to aid in the implementation of change.
Reviews and approves changes to QSR and DMR documentation as required.
Initiates site Change Plan and Document Change Request activities (as required) for changes identified through Product / Process improvement, Transfer activities and/or Identified compliance issues.
Co-ordinate and manage Change Plan and Document Change Requests through to closure, including tracking of identified deliverables and action items.
Work in conjunction with relevant Document/ Process owners to identify and organize CFTs.
Identifies areas for process improvement.
Attends process community meetings.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.CAPA: Acts as a SME for the CAPA system, involved in Process community and site meetings.
Coordinates quality decisions from a CAPA perspective at the site and ensures compliance to all aspects as applicable.Calibration: Ensure that the plant meets the quality requirements of its customers, Divisional & Corporate Policies with respect to Calibration, be involved in Cross Functional Teams at the site as required.Collate and Report on relevant Calibration data/matrices.Maintain and update the calibration system, issue calibration schedules to equipment owners and ensure that all required calibrations are completed in a timely manner.Initiate calibration non-conformances and liaise with equipment owners to ensure timely resolution of issues.Liase with external calibration contractors related to Calibration, co-ordinate opening meetings and control of activities, including initiation of purchase orders where required.Ensure that external calibration contractors are aware of any relevant procedural changes.Generally support on Calibration issues and queries.Knowledge, Skills & Experience Third Level Qualification in a relevant discipline OR relevant combination of education or experienceAt 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 improvementExcellent communication, team and organizational skills required.Ability to use own initiative and be proactive in the management of assigned tasks to set and meet deadlines.Ability to work co-operatively and effectively with others to establish and maintain good working relationships.
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