Software Quality Engineer at Abbott

Kilkenny, County Kilkenny, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

A degree in IT, Engineering, Science, or related discipline
4–5 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

Responsibilities

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

Skills

Software Validation

FDA Compliance

21 CFR Part 11

Data Integrity

GxP

ISO

Design Control

Risk Assessment

Validation Protocols

SOPs

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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