CAPA & Quality Improvement Lead

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 closure of CAPA/Deviation/Change Control records across sites, employing project management, Lean and structured 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, representing GE HealthCare during audits.

Relocation assistance provided: No

Qualifications

• Bachelor's degree in a relevant field.
• Significant Quality, Manufacturing or Engineering experience in a regulated industry (Medical Devices or Pharmaceuticals).

Responsibilities

• Analyses and evaluates inputs to the QMS record and ensures regulatory requirements are met.
• Manages execution of QMS records with project management and lean methods.
• Leads CAPA Review Boards with site leadership to address risks.
• Owns site trending and data analysis for CAPA/Deviation/Change inputs.
• Leads teams to apply problem solving and analysis techniques.
• Supports quality system audits and interfaces with regulators.
• Coaches others in the organization.

Skills

GMP/QMS knowledge

Project management

Lean methodology

Cross-functional leadership

Root-cause analysis

Excellent communication

Regulatory compliance

Education

Bachelor's degree

Tools

TWD system

Job description

GE HealthCare in Ireland is seeking a CAPA Leader to drive closure of CAPA/Deviation/Change Control records across sites, employing project management, Lean and structured 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, representing GE HealthCare during audits.

Relocation assistance provided: No