CAPA Leader: Quality Systems & Lean Problem Solver

GE HealthCare; Oslo fylke; On-site; NOK 1,200,000 - 1,600,000; Full time

Job summary

GE HealthCare is seeking a CAPA Leader to drive the closure of CAPA, Deviation and Change Control records across sites within the PDx network, applying project management, Lean methodologies and structured problem solving to deliver timely, high-quality quality system decisions.

In collaboration with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs, you will protect patient safety, strengthen quality systems and ensure regulatory compliance, while leading CAPA reviews and

Qualifications

• Bachelor's degree from an accredited university.
• Quality, manufacturing or engineering experience in a regulated industry (medical devices or pharmaceuticals).

Responsibilities

• Analyze and evaluate QMS inputs; escalate and document regulatory requirements.
• Manage execution of QMS records using PM, problem solving, and Lean methods.
• Lead CAPA Review Boards with site leadership.
• Own site trending and data analysis for CAPA/Deviation/Change Control.
• Lead teams to solve complex problems using statistical tools.
• Ensure site audit readiness and support QA system audits.
• Coach and develop others as an individual contributor.

Skills

Lean project management

Quality Assurance

Problem solving

Cross-functional collaboration

Communication

Education

Bachelor's degree

Tools

TWD system

Job description

GE HealthCare is seeking a CAPA Leader to drive the closure of CAPA, Deviation and Change Control records across sites within the PDx network, applying project management, Lean methodologies and structured problem solving to deliver timely, high-quality quality system decisions.

In collaboration with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs, you will protect patient safety, strengthen quality systems and ensure regulatory compliance, while leading CAPA reviews and