Senior Quality Engineer — Medical Devices & CAPA Expert

Abbott; Ireland; On-site; EUR 65,000 - 90,000; Full time

Job summary

Abbott in Ireland, Galway, is seeking a Senior Quality Engineer to support the ID Infectious Diseases unit. You will ensure Quality System compliance, drive continuous improvement, and participate in CAPA investigations across the site.

Role requires a science/engineering degree and 5–7 years in the medical device sector, with experience in ISO13485, ISO14971, and FDA/CE regulations; international travel ~5% is expected.

Qualifications

• Third level qualification in Science/Engineering.
• 5–7 years of experience in medical device industry with progressive responsibility.
• Competent working knowledge of Quality Management Systems and Global Medical Device regulations (ISO9001/ISO13485/ISO14971/cGMP/CE/FDA/PAL/IVDR/MDSAP).
• Experience with problem solving and CAPA investigations.
• Audit experience would be an advantage.
• Excellent interpersonal, written and verbal communication skills.
• Able to travel internationally (approximately 5% annually).

Responsibilities

• Actively stays current with external and internal quality systems standards and requirements providing quality systems support.
• Investigate complex product quality and compliance issues, analyze data, make recommendations and develop reports.
• Identify deficiencies in quality systems and define corrective actions; support continuous improvement.
• Develop quality metrics and communicate results to stakeholders; maintain management review records.
• Assist with change control, CAPA implementation and internal/external audits.

Skills

Quality systems knowledge

Problem solving

Communication skills

Project management

Interpersonal skills

Education

Science/Engineering degree

Tools

MS Office (Word, Excel, PowerPoint)

Job description

Abbott in Ireland, Galway, is seeking a Senior Quality Engineer to support the ID Infectious Diseases unit. You will ensure Quality System compliance, drive continuous improvement, and participate in CAPA investigations across the site.

Role requires a science/engineering degree and 5–7 years in the medical device sector, with experience in ISO13485, ISO14971, and FDA/CE regulations; international travel ~5% is expected.