Senior Quality Engineer – Medical Devices & CAPA Expert

Abbott; Galway; On-site; EUR 70,000 - 90,000; Full time

Job summary

Abbott is seeking a Senior Quality Engineer based in Galway to support the ID Business Unit's QMS integration and continual improvement. You will maintain compliance with procedures, lead CAPA investigations, and drive cross-functional quality improvements across sites.

You will mentor staff, participate in internal and external audits, update procedures via change control, and partner with senior stakeholders to ensure regulatory compliance and product quality in a fast-growing diagnostics

Qualifications

• Third level qualification in Science/Engineering.
• Experience in medical device industry and quality systems is required.
• Strong CAPA investigation and problem-solving skills.

Responsibilities

• Actively stays current with external and internal quality systems standards and requirements providing quality systems support.
• Investigate complex product quality and compliance issues (CAPA, non-conformances, audit observations), analyze data, make recommendations and develop reports.
• Identify deficiencies in quality systems and define corrective actions; support continuous improvement of quality system processes.
• Develop quality metrics and communicate results to stakeholders; maintain records for management review.
• Apply problem-solving skills to resolve moderately complex issues and drive cross-functional standardization and collaboration.
• Update and create quality procedures through change control; participate in internal and external audits across the BU.
• Train and coach staff on routine procedures and processes.

Skills

Quality Systems

CAPA investigations

Regulatory compliance

Problem solving

Auditing

Cross-functional

Communication

Team leadership

Travel

Education

Science/Engineering degree

Tools

MS Word

Excel

PowerPoint

Job description

Abbott is seeking a Senior Quality Engineer based in Galway to support the ID Business Unit's QMS integration and continual improvement. You will maintain compliance with procedures, lead CAPA investigations, and drive cross-functional quality improvements across sites.

You will mentor staff, participate in internal and external audits, update procedures via change control, and partner with senior stakeholders to ensure regulatory compliance and product quality in a fast-growing diagnostics