CAPA & Quality Excellence Leader

MS0234 GE Healthcare Ireland Limited; Cork; On-site; EUR 120,000 - 150,000; Full time

Job summary

GE HealthCare Ireland Limited is seeking an experienced CAPA Lead to strengthen CAPA, deviations, change control, investigations, and escalation across the quality management system. You will provide independent oversight of process health, identify risks and drive sustainable improvement throughout the product lifecycle.

You will develop and execute CAPA programs, lead quality events, and partner with senior leaders to ensure issues are addressed effectively and prevent recurrence.

Qualifications

• Experience in GxP regulated environments.
• Deep knowledge of CAPA, deviation management, investigations, change control.

Responsibilities

• Own and strengthen the process for CAPA, deviations, change control, investigations and escalation.
• Drive investigation excellence, including root cause analysis and recurrence prevention.
• Provide monitoring and oversight of end-to-end process performance and remediation effectiveness.
• Develop KPIs, trends and insights to proactively identify quality risks.
• Lead continuous improvement initiatives with key functions.
• Support inspection readiness and audits related to CAPA, deviations, investigations, change control and escalation.

Skills

CAPA governance

Root cause analysis

Change management

Quality metrics

Stakeholder influence

Tools

QMS (Quality Management System)

Job description

GE HealthCare Ireland Limited is seeking an experienced CAPA Lead to strengthen CAPA, deviations, change control, investigations, and escalation across the quality management system. You will provide independent oversight of process health, identify risks and drive sustainable improvement throughout the product lifecycle.

You will develop and execute CAPA programs, lead quality events, and partner with senior leaders to ensure issues are addressed effectively and prevent recurrence.