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    Software Quality Engineer - Kilkenny, Ireland - Abbott

    Abbott
    Abbott Kilkenny, Ireland

    1 week ago

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    Description

    Have you ever wanted to make a difference?

    At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

    Abbott Ireland

    In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.

    Diabetes Care Kilkenny

    Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.

    At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.

    This is how you can make a difference at Abbott:

    In this role you will be responsible for creating and implementing the Abbott Division validation program. Creating and maintaining validation documentation for new and existing systems and processes subject to design control. You will also ensure that validation activities are implemented for systems as per requirements and standards as listed in the Abbott's current Quality Systems Manual. You might also can travel to vendor locations for training in Europe or the US. Previous experience in implementing software projects from greenfield stage.

    You will be responsible of:

  • The validation and operational management of computerized systems.
  • The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
  • Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
  • Maintaining the quality and compliance status of associated Procedures, work instructions.
  • Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.

    • QUALIFICATIONS AND EXPERIENCE

  • Relevant third level qualification.IT/ Engineering/Manufacturing/Science is preferred.
  • 2-3 years working knowledge of software validation in med devices industry.
  • Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations

    • What we Offer

    Attractive compensation package that includes competitive pay, as well as benefits such as

  • Family health insurance,
  • Excellent pension scheme
  • Life assurance
  • Career Development
  • Fantastic new facility
  • Growing business plus access to many more benefits.

    • Abbott is an equal opportunities employer.

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