CAPA & Quality Improvement Leader

GE HealthCare; Cork; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

GE HealthCare seeks an experienced Quality leader to strengthen CAPA, deviations, change control, investigations and escalation across the product lifecycle. This role provides independent governance and drives sustainable improvement with data-driven insights.

As CAPA Lead, you will develop and execute CAPA programs, lead quality events, drive root cause analysis, monitor effectiveness and partner with senior leaders to ensure timely, robust issue resolution and regulatory readiness.

Formación

• Strong knowledge of CAPA, deviation management, investigations, change control and Quality Management Systems.
• Demonstrated governance and independent oversight across complex, cross-functional processes.
• Analytical with quality metrics and trending to identify risk and drive improvement.
• Ability to influence senior stakeholders and drive continuous improvement.

Responsabilidades

• Own and strengthen CAPA, deviations, change control, investigations, quality issue management and escalation.
• Drive investigation excellence, including root cause analysis, CAPA effectiveness and recurrence prevention.
• Provide independent monitoring and oversight of end-to-end process performance.
• Develop meaningful KPIs, trending and management insights for proactive quality risk escalation.
• Lead continuous improvement initiatives in partnership with key functions.
• Ensure significant quality and compliance issues are evaluated, escalated, investigated and resolved.
• Partner with senior leaders to maintain visibility of Quality Management System performance and risks.
• Support inspection readiness and regulatory or internal audit activities related to CAPA and deviations.
• Promote quality accountability and a proactive quality culture across boundaries.
• Participate in industry forums to bring external best practice into the organisation.

Conocimientos

CAPA

Deviation management

Investigations

Change control

Quality Management Systems

Root cause analysis

KPIs & trending

Stakeholder collaboration

Continuous improvement

GxP/regulatory knowledge

Descripción del empleo

GE HealthCare seeks an experienced Quality leader to strengthen CAPA, deviations, change control, investigations and escalation across the product lifecycle. This role provides independent governance and drives sustainable improvement with data-driven insights.

As CAPA Lead, you will develop and execute CAPA programs, lead quality events, drive root cause analysis, monitor effectiveness and partner with senior leaders to ensure timely, robust issue resolution and regulatory readiness.