Software Quality Engineer

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritionals and branded generic medicines. Our 114000 colleagues serve people in more than 160 countries.

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 Ireland Abbott currently employs about 6000 people across ten sites located in Dublin Donegal Clonmel Cootehill Galway Kilkenny Longford and Sligo.

Abbott Diabetes Care Kilkenny

Abbott Diabetes Care has opened a new site in Kilkenny that is at the forefront of Diabetes care with the latest technology to manufacture 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 systems.

Make a Difference at Abbott

Join a global leader in healthcare and help shape the future of software quality and this role you will ensure that all computerized systems and software used in regulated processes meet stringent quality standards and comply with global regulations.

What Youll Do:

• Lead software validation activities for new and existing systems ensuring compliance with design control and regulatory requirements.

• Develop and maintain validation documentation (protocols reports risk assessments) aligned with FDA ISO and Abbott policies.

• Perform software compliance assessments for regulations such as 21 CFR Part 11 Data Integrity and applicable GxP guidelines.

• Maintain and improve SOPs and work instructions related to software quality and validation.

• Monitor and report key quality metrics trends and continuous improvement initiatives to stakeholders.

• Collaborate with cross-functional teams to ensure robust software lifecycle management from development through deployment.

What Were Looking For:

• A degree in IT Engineering Science or related discipline.

• 45 years of experience in software validation or compliance within a medical device or regulated healthcare environment.

• Strong knowledge of 21 CFR 820 ISO 13485 and software lifecycle standards (e.g. IEC 62304).

• Experience implementing and validating computerized systems and software applications from concept to production.

• Familiarity with risk-based validation approaches and data integrity principles.

• Ability to travel to vendor sites in Europe or the US for training and audits.

Why Abbott

Youll work in a dynamic environment where innovation meets compliance ensuring patient safety and product quality worldwide. Join us to set the standard for software quality excellence in healthcare technology.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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