Lead Auditor, Quality Compliance — Medical Devices

Integra LifeSciences (Ireland) Ltd; Tullamore; On-site; EUR 90,000 - 130,000; Full time

Job summary

Integra LifeSciences is seeking a Lead Auditor, Quality Compliance to drive the corporate audit program across more than 15 design, manufacturing, and distribution facilities. You will lead audits of the QMS, report findings, and guide sites toward regulatory and quality improvements.

The role requires extensive auditing experience in medical devices or pharmaceuticals, with strong regulatory knowledge and global collaboration. International travel up to 50% is expected.

Qualifications

• Bachelor’s degree in engineering, or sciences or relevant technical field.
• Minimum 15 years of auditing experience in quality, manufacturing, or engineering.
• Formal Auditor certification by a recognized body.
• Experience with FDA, ISO 13485, EU MDR, and MDSAP requirements.
• Willingness to travel up to 50% internationally.

Responsibilities

• Lead, coordinate and perform corporate audits of the QMS across multiple facilities.
• Provide formal written audit reports with executive summaries for leadership.
• Identify and address areas for improvement in site quality systems.
• Support site inspection readiness through corporate audits and CAPA reviews.
• Coach and mentor site teams and other Integra personnel in auditing practices.

Skills

Lead Auditor

Quality Compliance

GMP/GDP/GLP/GCP

Regulatory Auditing

Cross-functional collaboration

Education

Bachelor’s degree in engineering or sciences

Master’s degree preferred

Auditor certification (IRCA/ASQ CQA/BSI/Exemplar Global)

Job description

Integra LifeSciences is seeking a Lead Auditor, Quality Compliance to drive the corporate audit program across more than 15 design, manufacturing, and distribution facilities. You will lead audits of the QMS, report findings, and guide sites toward regulatory and quality improvements.

The role requires extensive auditing experience in medical devices or pharmaceuticals, with strong regulatory knowledge and global collaboration. International travel up to 50% is expected.