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Software quality engineer

Kilkenny
Abbott
Quality engineer
€80,000 - €100,000 a year
Posted: 1 May
Offer description

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Have you ever wanted to make a difference?

At Abbott, you will play a crucial role in helping people live more fully at all stages of their lives. Abbott is a global healthcare leader with a portfolio of life-changing technologies spanning diagnostics, medical devices, nutritional products, and branded generic medicines. Our 113,000 colleagues make a daily impact on lives in over 160 countries.

Abbott Ireland

In Ireland, Abbott employs around 6,000 people across ten sites, including manufacturing facilities in Clonmel, Cootehill, Donegal, Longford, and Sligo, as well as commercial, support operations, and shared services in Dublin and Galway. Since 1946, Abbott has been making a difference in Irish lives.

Diabetes Care Kilkenny

Our new Kilkenny manufacturing facility, opening in 2024, will focus on Abbott's Diabetes Care products, including the FreeStyle Libre 3. This system provides real-time glucose readings and optional alarms, enabling people with diabetes to live better lives.

At Abbott Kilkenny, you can shape your career while helping shape the future of healthcare.

Role Overview:

In this role, you will be responsible for creating and implementing the Abbott Division validation program, maintaining validation documentation, and ensuring validation activities meet standards. You may also travel to vendor locations in Europe or the US for training. Experience in software projects from greenfield stage is preferred.

Responsibilities

* Validation and operational management of computerized systems.
* Creation and review of validation documentation per regulatory requirements.
* Develop Software Compliance assessments like 21 CFR Part 11 and Data Integrity.
* Maintain quality and compliance of procedures and work instructions.
* Present status reports, identify trends, and suggest improvements.
Qualifications and Experience
* Relevant third-level qualification in IT, Engineering, Manufacturing, or Science (preferred).
* 2-3 years of software validation experience in the medical devices industry.
* Experience with cybersecurity assessments.
* Experience in a 21 CFR 820 and/or ISO 13485 regulated environment; pharmaceutical validation experience is also considered.
What We Offer
* Competitive salary and benefits including family health insurance, pension scheme, and life assurance.
* Career development opportunities.
* Access to a new, state-of-the-art facility.
* Growing business with many benefits.
Connect with us at www.abbott.com, https://www.ie.abbott/, LinkedIn, Facebook, and Twitter. Abbott is an equal opportunities employer.


Seniority level

* Associate


Employment type

* Full-time


Job function

* Quality Assurance


Industries

* Hospitals and Health Care

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