QA Manager for Abbott Rapid Diagnostics Galway, responsible for implementing quality systems, leading QA teams, and ensuring compliance with regulations and standards.
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 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 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.
This QA Manager position is focused on supporting the establishment of Abbott Rapid Diagnostics Galway as a legal manufacturer entity for select on-market and new products. Additionally, this role is focused on supporting the implementation & maintenance of Abbott's Quality System in alignment with applicable regulations and standards including ISO 13485, FDA 21 CFR 820, WHO, etc. The Quality Professional leads activities assigned to them, collating needed inputs and working collaboratively with a broad cross-functional team.
Main Responsibilities:
Scope:
Receives general direction and exercises considerable discretion to work on own detail. Recommends possible solutions. Oversees a team of QA professionals, including manager and team leader levels.
Education:
Bachelor's degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
Experience:
At least 8 years of work experience in a related field; less experience may be appropriate with an advanced degree.
Preferred experience in the Healthcare industry. Previous people management experience is an advantage.
Has a history of completing successful projects and driving positive compliance outcomes.