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 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 support significate growth for Abbott in COVID-19 related products in over 70+ countries.

PURPOSE OF THE JOB:

The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of Abbott Galway International’s Quality Management Systems and in Quality related projects.   The Quality Engineer reports to the QA Manager at RDIL.

MAJOR RESPONSIBILITIES:

• Identifies problems and possible solutions and takes appropriate action to resolve.

• Demonstrates skill in data analysis techniques.

• Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues.

• Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results.  Applies risk assessment techniques in such circumstances. 

• Investigation & appropriately documenting non-conformance & CAPA.

• Possesses and applies a broad and increasing knowledge of Quality to the completion of moderately complex assignments.

• Drives business improvements through continuous improvement initiatives.

• Escalation point for quality related non-conformances and CAPAs.

• Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification. 

• Drives compliance across departments and Business Units through communication and collaboration to ensure that Quality System requirements are met throughout.

• Participate in internal and external audit.

EDUCATION & COMPETENCIES:

• Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions

• Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.

• Proficient with MS Word, Excel, Power Point, and management of spreadsheets.

• Third level qualification.

• Minimum 3 years of experience in medical device industry with progressively responsible positions including;

• Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),

• Awareness of relevant laws and regulations (e.g. MDR / IVDR / FDA)

• Broad knowledge of engineering and technical applications applied in development of medical devices & IVD’s useful.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.