- Assist in the development of software systems & policy compliance to regulatory requirements including, FDA QSRs, ISO13485 & IVDD.
- CSV experience to ensure compliance with GMP, and Data Integrity requirements on all systems.
- Collaborate and support digital and data analytics projects.
- Ensure validation and qualification activities of processes, methods, and equipment comply with internal requirements and applicable regulations and standards.
- Experience, and understanding of Software Change Control
- Analyse quality and process data using statistical techniques to identify trends.
- 3rd Level Degree in an Engineering, Computer Systems or Science discipline.
- A minimum of 2 years experience in full Software Lifecyle activities / SDLC, CAPA systems, ALCOA Principles, and leading on quality software projects ideally in Medical Device or Pharmaceutical manufacturing
- Proficient Microsoft office suite
- Strong problem solving and analysis skills
- Proven presentation experience
- Family health insurance,
- Excellent pension scheme
- Life assurance
- Career Development
- Fantastic new facility
- Growing business plus access to many more benefits.
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Software Quality Engineer - Kilkenny, Ireland - Abbott Laboratories
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:
To support the development and onward growth of our Kilkenny site, we have an exciting opportunity for a Software Quality Engineer to join the team. In this role you can grow your career as you help Abbott shape the future of healthcare.
***Please note we are building a talent pipeline for Software Quality Engineer positions due to start in late 2024***
QUALIFICATIONS AND EXPERIENCE
What we Offer
Attractive compensation package that includes competitive pay, as well as benefits such as
Connect with us at or , on LinkedIn at , on Facebook at and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
Connect with us at or , on LinkedIn at , on Facebook at and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.