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.

MAJOR RESPONSIBILITIES:

• Reporting to the Director of Quality Operations IDEM, the PM role will provide oversight on all quality related projects on-going within IDEM.

• These projects include a variety of Abbott Integration programs across IDEM manufacturing and commercial sites such as QMS Remediation/Project Shannon/Re-Branding/IVDR etc.

• Will work closely with the site QA and RA Leads as well as the designated Corporate and Divisional Project PM’s to track project milestones, develop a review process with Site Leads , and influence action plans to support the achievement of project deliverables.

• Will be the primary IDEM quality representative at the established Project Review forums providing site updates and communicating any project changes/impact to stakeholders.

• Act as the key connection/communication point between Site QA /RA leads and the PM’s of the various projects.

• Develop a standard dashboard for all projects so that all stakeholders including the Site leads and VP of quality have continuous oversight of projects progress, key risks, decisions needed, and corrective action plans where required.

• Develop project management as a key skill across the IDEM quality community and ensure a standard approach to project management.

• Lead and execute specific quality projects within the IDEM QA function as well as being primary point of contact for all Corporate and Divisional quality projects.

EDUCATION & COMPETENCIES:

• Third Level Qualification in related field (Science, engineering or nursing preferable)

• Minimum 8 years of experience in medical device industry with minimum 3 years of progressively responsible positions, including; Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)

• Experience working in electronic complaint management systems

• Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness.

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

• Excellent computer skills including all MS Office applications

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

• Able to travel internationally (approximately 15% annually)

• Experience supporting in-vitro diagnostics products

• Broad knowledge of engineering and technical applications applied in development of medical devices useful

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