Senior Quality Engineer at Abbott

Galway, County Galway, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Expertise in quality assurance, project execution, and business analysis
Knowledge of ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards
Ability to interpret regulations, perform gap analysis, and implement improvements
Skills in risk assessment and problem-solving for complex quality and system issues

Responsibilities

Coordinate cross-functional efforts across Quality, IT, and other business units to implement and maintain robust quality system processes
Ensure compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements
Support the development, enhancement, and maintenance of enterprise-wide quality applications, including complaint handling, CAPA, audit management, and document control
Manage project scope, timelines, risks, and resources to ensure successful execution of quality-related initiatives
Analyze business needs and translate them into actionable project plans, system requirements, and process improvements
Conduct stakeholder reviews to prioritize system enhancements and ensure alignment with business and regulatory objectives
Monitor project performance and communicate progress through reports and dashboards to stakeholders and leadership
Apply risk assessment and problem-solving techniques to resolve complex quality and system issues
Support internal and external audits, perform gap analyses, and lead implementation of compliance improvements
Investigate and resolve quality system nonconformances (defined during internal and/or external audits)
Analyze quality audit findings and recommend modifications

Skills

Quality Engineering

Quality Assurance

Diagnostics

Medical Devices

GMP

ISO 13485

Root Cause Analysis

CAPA

Validation

Auditing

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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