Quality Engineer - Third Party Manufacturing

Job description

JOB DESCRIPTION:

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150+ countries and employs approximately 97,000 people.

In Ireland, Abbott has five business units, represented across eight manufacturing sites. The Abbott Diabetes Care division is based in Donegal Town with our Third Part Manufacturing sites based in Cork (Fermoy) and Dublin. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system. In the North West of Ireland, we are currently going through a significant expansion as we introduce new technology and machinery to manufacture the Libre Freestyle Sensor which is revolutionary in the care and management of Diabetes. As part of the expansion we have an immediate requirement for an experienced Quality Engineer to work in our Third Party Manufacturng site.

Purpose of the role:

• Ensure functional area is compliant to site and divisional policies and procedures.
• Support the continuous improvement and effective maintenance of the QMS
• Ensure the use of appropriate risk management tools to prioritise activities and the level of effort required
• Support the building and maintenance of successful cross functional relationships with departments such as R&D, Technical, Engineering, Operations and Regulatory Affairs in order to achieve all project goals
• Manage own and support the teams Health and Safety within the working environment highlight opportunities for improvement to EHS performance

Main responsibilities:

• Responsible for the monitoring and maintenance of the validation status of site products, processes and systems
• Reviewing and approval of protocols and reports for Software, Facilities Utilities Equipment (FUE), Test Method, and Process (including pFMEA, sterilisation and product integrity) validations
• Maintenance of the site validation plans, listings and periodic review process
• Change control process including, assessment of impact and review, approval and authoring of documentation
• Monitoring and maintenance of the design control status of site products, processes and systems:
• Maintenance of Risk Management plans and associated records e.g. design risk analysis and design FMEA
• Identifying and raising Quality / Compliance issues, reviewing Exception Reports (ERs) and confirming Corrections and Corrective Actions
• Identifying projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.
• Responsible for the development and implementation of continuous improvements plans

Qualifications & Experience:

Science or Engineering degree

Minimum of 3 years' experience in a GMP environment

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