Kieran Fitzgerald

Serves as the Organisation's Management Representative, hosting FDA and ISO 13485 audits and successfully retaining ISO 13485 certification within 7 months. Established a new organisational framework for Quality, onboarded a new Quality team, and managed the calibration program.

Reported directly to the CTO and managed Kneat's Quality Management System to satisfy ISO 9001, ISO 27001, GAMP 5, and 21 CFR Part 11. Expanded the Quality team from 3 to 10 staff and achieved ISO 27001 certification within 6 months.

Managed Kneat's Quality Management System to satisfy ISO 9001, ISO 27001, GAMP 5, and 21 CFR Part 11. Expanded the Quality team from 3 to 10 staff and achieved ISO 27001 certification within 6 months.

Served as Head of Quality with ownership of a dual-site Quality Management System. Managed installation and validation of a class 8 clean room, achieved dual site ISO 13485 certification within 12 months, and led contract manufacturing transfers and NPI.

Operations manufacturing management role to develop site capability in Lean and Six Sigma through defined development programs, coaching, and mentoring. Defined, managed, and sustained a 6S culture and drove Stryker Production System implementations.

Quality Lead for two value streams, developing and managing site NC reduction program. Led site CAPA activities, customer complaint investigations, NCs, risk management, and root cause investigations.

Served as MSc Master Black Belt Thesis Supervisor and Specialised Diploma Black Belt Supervisor, developing and delivering lean methodology course material.

Served as site QE lead for change management, maintenance, utilities, calibration, manufacturing transfers, and engineering projects. Certified validation engineer and site Emergency Change Request quality approver.

Served as site QE lead for change management, maintenance, utilities, calibration, manufacturing transfers, and engineering projects. Certified validation engineer and site Emergency Change Request quality approver.

Served as site QE lead for change management, maintenance, utilities, calibration, manufacturing transfers, and engineering projects. Certified validation engineer and site Emergency Change Request quality approver.

Site Lead for process excellence, lean, and six sigma deployment and development. Successfully managed the site manufacturing equipment excellence program (ME2) and achieved the highest level in the JnJ Lean Maturity Assessment.

Specialist in process excellence, supporting lean and six sigma initiatives.

Delivered business improvement and technical training to support operational excellence.

Led process technician line operations, ensuring production efficiency and quality.

MSc in Strategic Quality Management – Lean Sigma Systems with Master Black Belt Certification.

Specialist Diploma in Lean & Quality Systems with Black Belt Certification.

BSc Degree in Innovation / Innovation Design.

HETAC National Diploma in Electronic Engineering.