Senior Quality Engineer – CAPA & Compliance (Global)

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

Job summary

Abbott in Ireland is seeking a Senior Quality Engineer based in Galway to support the ID Business Unit's QMS integration and continuous improvement. You will ensure compliance, lead investigations, and drive quality system enhancements across the site.

The role requires a third-level Science/Engineering degree and 5–7 years in medical devices with strong knowledge of ISO and global regulations, CAPA activity, and audit readiness. Travel ~5% may be expected.

Qualifications

• Third level qualification in Science/Engineering.
• 5–7 years in medical device industry with 5+ years in progressive roles.
• Strong knowledge of QMS and global medical device regulations (ISO9001/ISO13485/ISO14971/cGMP/CE/FDA/IVDR/MDSAP).
• Experience with problem solving and CAPA investigations.
• Audit experience would be an advantage.
• Excellent interpersonal, written and verbal communication skills.
• Pro-active attitude, excellent organization, and ability to manage multiple projects with travel ~5% annually.

Responsibilities

• Actively stays current with external and internal quality systems standards and requirements providing quality systems support.
• Possesses and applies a broad and increasing knowledge of Quality, and its application within the ID Business Unit.
• Investigate complex product quality and compliance issues (e.g. CAPA, non-conformances, audit observations), analyze data, make recommendations and develop reports.
• Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes.
• Develops effective quality metrics and communicates results to key stakeholders. Preparation and maintenance of records associated with the management review process.
• Applies problem-solving skills to deal creatively with moderately complex situations and coordinates corrective actions.
• Drives compliance cross functionally in alignment with the Business Unit objectives.
• Update and create quality procedures through the change control process.
• Participate and support internal and external audits across the BU.
• Implement the CAPA system ensuring root cause analysis and corrective/preventive actions.

Skills

Interpersonal communication

Problem solving

Organizational skills

Travel ability

Education

Science/Engineering degree

Tools

MS Word

Excel

PowerPoint

Job description

Abbott in Ireland is seeking a Senior Quality Engineer based in Galway to support the ID Business Unit's QMS integration and continuous improvement. You will ensure compliance, lead investigations, and drive quality system enhancements across the site.

The role requires a third-level Science/Engineering degree and 5–7 years in medical devices with strong knowledge of ISO and global regulations, CAPA activity, and audit readiness. Travel ~5% may be expected.