CAPA & Quality Improvement Lead

GE HealthCare (United States); Oslo fylke; On-site; NOK 900,000 - 1,200,000; Full time

Job summary

GE HealthCare is seeking a CAPA Leader to drive timely, high-quality QMS record outcomes across PDx sites. You will lead CAPA/Deviation/Change Control processes, apply Lean problem solving, and collaborate with Quality, Supply Chain, Operations, Engineering, and Regulatory Affairs to protect patient safety and ensure regulatory compliance.

You will interface with internal teams and external audits, contributing to site readiness and cross-functional risk mitigation.

Qualifications

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

Responsibilities

• Ensure all areas of the QMS are analyzed and evaluated for input to the QMS record, problems escalated and documented.
• Manage execution of the QMS records using project management, problem solving, and lean methodologies.
• Lead CAPA Review Boards with site leadership to address risks proactively.
• Own site trending and data analysis for inputs to CAPA/Deviation/Change Control processes.
• Lead others to find creative solutions using statistical and analysis techniques.
• Ensure site audit readiness and support Quality System audits; represent GE HealthCare externally.
• Coach and develop others in the organization as an individual contributor

Skills

Quality leadership

Project management

Lean

Cross-functional collaboration

Education

Bachelor's degree

Job description

GE HealthCare is seeking a CAPA Leader to drive timely, high-quality QMS record outcomes across PDx sites. You will lead CAPA/Deviation/Change Control processes, apply Lean problem solving, and collaborate with Quality, Supply Chain, Operations, Engineering, and Regulatory Affairs to protect patient safety and ensure regulatory compliance.

You will interface with internal teams and external audits, contributing to site readiness and cross-functional risk mitigation.