Compliance Engineer

Job description

JOB DESCRIPTION:Abbott in Ireland Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo. 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. 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. MAJOR RESPONSIBILITIES CAPA -Complete the Impact assessment and investigation of non-conformances associated with non-conforming products, out of Specifications (OOS), audit findings and customer complaints. OOS -Member of cross functional investigation team to ensure OOS investigations are completed in accordance with procedural requirements. Audit Readiness – Support Ops Manufacturing, ensure compliance across all areas. Contributing to the creation and update where relevant of Work Instructions and Operation procedures to maintain compliance. Manage the Equipment Assets on site, maintain and update the Asset Management / Maintenance System. Supporting the engineering team in ensuring that facilities, utilities and equipment are maintained to meet the required standards. Maintain and manage the change control of updating the Asset management / Maintenance system. Develop Continuous Improvement Plans and activities as related to manufacturing and quality process. Coordinate and implement process and equipment projects. Identification of opportunities for new technology and driving continuous improvement. Manage and review the Operation KPI’s, (e.g. NC Closure Rate, Track & Trend, PM’s completed) Review Change Control Documents and support the approval process of updated documents. Ensure adherence to 6 S in the Operation areas ensuring the department conducts its business in a manner designed to be protective of human health, safety and the environment. Maintain strong communication and working relationships with all departments. Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management. Complete Tasks as assigned by Lead. EDUCATION AND COMPETENCIES REQUIRED Educated Third level qualification in Engineering / Manufacturing / Science disciplines 4 years experience in a similar environment preferred. Excellent communication / interpersonal skills Enthusiastic and energetic with the ability to integrate quickly into a fast pace team environment The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY:Engineering DIVISION:ADC Diabetes Care LOCATION:Ireland > Donegal Town : R267 ADDITIONAL LOCATIONS: WORK SHIFT:Ie - Dl39S8 (Ireland) TRAVEL:No MEDICAL SURVEILLANCE:Yes SIGNIFICANT WORK ACTIVITIES:Not Applicable