Regional CAPA & Quality Leader, PDx Excellence

GE HealthCare; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

GE HealthCare in Ireland is seeking a CAPA Leader to drive the closure of CAPA/Deviation/Change Control records across sites. The role emphasizes timely, high-quality QMS outcomes through project management, Lean methods, and collaborative problem solving.

You will partner with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to protect patient safety, improve product quality, and ensure regulatory compliance.

Qualifications

• Bachelor's degree from an accredited university or college.
• Quality, Manufacturing or Engineering experience in a regulated industry (Medical Devices or Pharmaceuticals).

Responsibilities

• Ensure QMS areas are analyzed and regulatory requirements met.
• Manage execution of QMS records using project management and Lean methods.
• Lead CAPA Review Boards and work with site leadership to address risks.
• Own site trending and data analysis for CAPA/Deviation/Change Control.
• Guide teams to solve complex problems using statistical analysis.
• Maintain audit readiness and represent GE HealthCare to external agencies.
• Coach and develop others within the organization.

Skills

Quality management

Lean

Project management

Problem solving

Cross-functional collaboration

Regulatory knowledge

Audits experience

Leadership

Education

Bachelor's degree

Job description

GE HealthCare in Ireland is seeking a CAPA Leader to drive the closure of CAPA/Deviation/Change Control records across sites. The role emphasizes timely, high-quality QMS outcomes through project management, Lean methods, and collaborative problem solving.

You will partner with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to protect patient safety, improve product quality, and ensure regulatory compliance.