CAPA Leader, Regional Quality (PDx) | Hybrid

MS0171 GE Healthcare UK Limited; Amersham; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

GE HealthCare in Amersham, England, is seeking a CAPA Leader to drive closure of CAPA/Deviation/Change Control records across sites. You will apply project management, Lean, and structured problem solving to protect patient safety and regulatory compliance, partnering with Quality, Supply Chain, Operations, Engineering, and Regulatory Affairs.

You will lead CAPA Review Boards, own data analysis, ensure audit readiness, and coach colleagues.

Qualifications

• Bachelor’s degree from an accredited university.
• Experience in Quality, Manufacturing or Engineering in a regulated industry (Medical Devices or Pharmaceuticals).
• Knowledge of GMP QMS and regulatory requirements.

Responsibilities

• Ensure QMS areas analyzed and regulatory requirements met.
• Manage execution of QMS records using PM, problem solving, and lean methodologies to ensure robust quality decisions.
• Lead CAPA Review Boards with site leadership to proactively address risks.
• Own site trending and data inputs to the CAPA/Deviation/Change Control process.
• Coach and develops others as an individual contributor.

Skills

Quality management

Lean methodologies

Problem solving

Cross-functional leadership

GMP knowledge

Regulatory compliance

Education

Bachelor's degree

Tools

TWD system

Job description

GE HealthCare in Amersham, England, is seeking a CAPA Leader to drive closure of CAPA/Deviation/Change Control records across sites. You will apply project management, Lean, and structured problem solving to protect patient safety and regulatory compliance, partnering with Quality, Supply Chain, Operations, Engineering, and Regulatory Affairs.

You will lead CAPA Review Boards, own data analysis, ensure audit readiness, and coach colleagues.