CAPA Lead

Job description

JOB DESCRIPTION: Abbott in Ireland Operating since 1946, Abbott serves the Irish market with a diverse range of healthcare products. We employ around 6,000 people across ten sites in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford, and Sligo. Abbott Ireland Diabetes Care Division Donegal: Located in Donegal Town, our Diabetes Care division manufactures FreeStyle blood glucose test strips and sensors, including the FreeStyle Precision, FreeStyle Lite, and FreeStyle Libre systems. Abbott Ireland Diabetes Care Division Donegal The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system. Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company Primary Function The CAPA Lead is responsible for the oversight, coordination, and continuous improvement of the site's Corrective and Preventive Action (CAPA) system. The role ensures that quality issues, non-conformances, audit observations, deviations, and other quality events are effectively investigated, root causes identified, and sustainable corrective and preventive actions implemented in compliance with regulatory requirements and company quality standards. The CAPA Lead drives quality excellence by ensuring timely closure of CAPAs, monitoring system performance, and promoting a culture of continuous improvement across the organization. Major Responsibilities Lead and manage the site CAPA program in accordance with applicable regulatory and company requirements. Ensure CAPAs are initiated, investigated, and closed within established timelines. Review CAPA records for completeness, accuracy, and compliance. Facilitate root cause investigations using appropriate problem-solving methodologies. Ensure corrective and preventive actions are effective, measurable, and sustainable. Verify CAPA effectiveness through follow-up reviews and effectiveness checks. Monitor and trend CAPA metrics, identifying recurring issues and systemic risks. Drive continuous improvements to CAPA processes and quality systems. Provide day-to-day guidance and support to CAPA team members Lead and promote Continuous Improvement initiatives within the department Coach and mentor CAPA team members, conducting performance reviews with a focus on growth Qualifications & Experience Relevant 3rd level qualification. Engineering / Manufacturing / Science preferred Minimum 5 years’ experience in Engineering / Manufacturing / Scientific Supervisor experience Strong Regulatory and Compliance knowledge Capable of analysing data to support the development of strategies to effectively manage the action plans that will resolve the issues. Ability to communicate, understand and direct individuals in highly specialized technical fields. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ADC Diabetes Care LOCATION: Ireland > Donegal Town : R267 ADDITIONAL LOCATIONS: WORK SHIFT: Ie - Dl39S9.3 (Ireland) TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable