CAPA & Quality Systems Lead

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

Benefits offered by this job

Restaurant d'entreprise

Job summary

GE HealthCare in Lombardy seeks a CAPA Leader to drive closure of CAPA/Deviation/Change Control records across sites, leveraging project management, Lean, and structured problem solving to ensure timely, compliant QMS outcomes. You will partner with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to protect patient safety and improve product quality.

You will represent GE HealthCare during audits and interface with regulatory authorities, coaching teams and leading CAPA

Qualifications

• Bachelor's degree in a relevant field.
• Significant Quality, Manufacturing or Engineering experience in a regulated industry (Medical Devices or Pharmaceuticals).
• Experience with CAPA, Deviation, and Change Control processes and GMP QMS.

Responsibilities

• Ensures all areas of the QMS are analyzed and evaluated for input to the QMS record and regulatory requirements are met.
• Manages execution of the QMS records using project management, problem solving, and lean methodologies to ensure timely, robust decisions.
• Leads CAPA Review Boards and partners with site leadership to address risks.
• Owns site trending and data analysis for CAPA/Deviation/Change Control inputs.
• Leads others to develop solutions using statistical and analysis techniques.
• Ensures site audit readiness and supports external audits and interfaces with regulatory authorities.

Skills

CAPA / QMS Leadership

Cross-functional collaboration

Lean methodologies

Problem solving & root cause

Education

Bachelor's degree

Tools

TWD system

Job description

GE HealthCare in Lombardy seeks a CAPA Leader to drive closure of CAPA/Deviation/Change Control records across sites, leveraging project management, Lean, and structured problem solving to ensure timely, compliant QMS outcomes. You will partner with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to protect patient safety and improve product quality.

You will represent GE HealthCare during audits and interface with regulatory authorities, coaching teams and leading CAPA