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 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 Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now supports significant growth for Abbott in COVID-19 related products in over 70+ countries.
We have an exciting opportunity for a Quality Engineer. The person will support in closing Quality Records with the Logistics and Distribution Subject Matter Expert (SME's).
MAJOR RESPONSIBILITIES: Possesses and applies a broad and increasing knowledge of Quality to the completion of moderately complex assignments.Identifies problems and possible solutions and takes appropriate action to resolve.In regard to Corrective and Preventative Action (CAPA) process the Quality Engineer will assist the team to ensure compliance to applicable standards.For the Quality Incident process also ensure compliance to applicable standards. Write and maintain the Logistics teams SOPs, provide training, develop and generate relevant metrics and trending.Assist or Perform gap assessment and Implement Corporate Policy requirements under the Quality system of the Distribution Centres.Identify and mitigate any supply Chain quality risks plus provide quality input to current processes and facilitate Quality Improvement initiatives.In addition is involved with the Logistics Distribution team within the Abbott Document Control system support the writing of new Quality System documents or maintenance of existing documents, processing document change requests and coordinating the approval of SOPs, Work Instructions and Forms.Provide Logistics supplier audit metrics which may be used in support of Management Review.Document and execute validation protocols needed to ensure Quality System and Regulatory compliance at the Distribution Centres or other sites as needed.Support the environmental validations in the Distribution Centres as needed.Perform and support internal, Abbott site and supplier audits as required.All duties to be completed in compliance with established business policies.EDUCATION & COMPETENCIES: Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science or related technical field or equivalent experience and education.3+ years' experience in a medical device company in a quality or regulatory function.Demonstrated experience with applicable regulatory standards and requirements.Ability to apply statistical tools in complaint trend analysis and utilize data analysis methodologies.Strong communication skills (written & verbal across cultures).Highly numerate with an aptitude for analysis.JOB FAMILY: Operations Quality
DIVISION: RMDx Rapid and Molecular Diagnostics
LOCATION: Ireland > Galway : Parkmore East Business Park
WORK SHIFT: Ie - 37.5Hst0 (Ireland)
TRAVEL: Not specified
MEDICAL SURVEILLANCE: No
SIGNIFICANT WORK ACTIVITIES: Not Applicable
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