CAPA Leader: Drive QMS Excellence Across Functions

GE HealthCare; Cork; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

GE HealthCare is seeking a CAPA Leader to oversee closure of CAPA/Deviation/Change Control records across sites, driving timely, high-quality QMS outcomes through project management, Lean methods and structured problem solving.

You will collaborate with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to apply problem solving tools that protect patient safety, strengthen quality systems, and ensure regulatory compliance.

Qualifications

• Bachelor's degree from an accredited university.
• Quality, manufacturing or engineering experience in regulated industries (Medical Devices or Pharmaceuticals).

Responsabilités

• Ensure QMS areas are analyzed, issues escalated, and regulatory requirements met.
• Manage execution of QMS records using PM, problem solving and lean methods.
• Lead CAPA Review Boards and partner with site leadership to address risks.
• Own site trending and data analysis for CAPA/Deviation/Change Control.
• Coach and develop others as individual contributors.
• Ensure site audit readiness and support external audits.

Connaissances

Project management

Lean methods

Quality systems

Cross-functional collaboration

Analytical thinking

Regulatory compliance

Effective communication

CAPA/Deviation handling

Formation

Bachelor's degree

Description du poste

GE HealthCare is seeking a CAPA Leader to oversee closure of CAPA/Deviation/Change Control records across sites, driving timely, high-quality QMS outcomes through project management, Lean methods and structured problem solving.

You will collaborate with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to apply problem solving tools that protect patient safety, strengthen quality systems, and ensure regulatory compliance.