Quality Systems Approver (Fixed Term Contract) (BB-DEBFA)
Found in: Talent IE
Description:About AbbottAbbott 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 109,000 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 4,000 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 Diagnostic Division SligoAbbott Diagnostics 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.ObjectiveTo ensure that the Quality System of the Abbott Diagnostics Sligo follow Division and site Quality System requirements and recognised international standards.Primary functionConduct quality-related activities to deliver consistent, high-quality documents, services, products and processes, which adds value to the business.Responsibilities Include: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.Maintains awareness of standards that regulate our industry. Ensures compliance with site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.Applies Risk Management principles to work.Assist initiators of change control documentation, including change plans, design plans and change requests (as required) to aid in the implementation of change.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. Coordinate 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.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). Acts as an 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.Provide leadership, clear direction and define priority during all activities in area of responsibility.Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager.Education and Experience Required:At least 3 years of work experience in Quality or related field experience; Less experience may be appropriate with an advanced degree.Excellent 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 cooperatively and effectively with others to establish and maintain good working relationships.Connect with us at or , on LinkedIn at , on Facebook at and on Twitter @AbbottNews.
calendar_today6 days ago