Global Quality Compliance Lead Auditor

Integra LifeSciences Corporation; Ireland; Remote; EUR 90,000 - 120,000; Full time

Job summary

Integra LifeSciences Corporation is seeking a Lead Auditor, Quality Compliance to lead and coordinate corporate audits of the Quality Management System across multiple facilities and sites. The role requires strong knowledge of GMP/GDP, EU regulations, and regulatory expectations, with travel up to 50% internationally.

You will prepare audit reports, drive improvements, and coach sites toward higher quality standards while collaborating across departments and with external suppliers.

Qualifications

• Experience performing corporate, site and supplier GMP/GDP/GLP/GCP audits in medical devices or pharma.
• Experience auditing EU CE files and working with regulatory bodies is a plus.
• Formal auditor certification by IRCA, ASQ CQA, BSI or Exemplar Global is preferred.
• Familiarity with 21 CFR Part 820 and ISO 13485 is advantageous.
• Willingness to travel up to 50% internationally.

Responsibilities

• Lead and coordinate corporate audits of the QMS across multiple sites and facilities.
• Prepare formal audit reports with observations, recommendations and site classifications.
• Identify improvement opportunities and coach sites to achieve compliance levels.
• Support inspection readiness and conduct CAPA reviews and mock inspections.
• Drive improvements in audit processes and ensure timely reporting.
• Provide technical auditing expertise to internal teams and approved suppliers.
• Participate in continuous quality initiatives and cross‑functional collaboration.

Skills

GMP/GDP audits

EU medical devices regs

Audit methodology

Cross-functional collaboration

Travel readiness

Education

Bachelor's in engineering/sciences

Master’s degree preferred

Auditor certification (IRCA/ASQ/BSI)

15+ years auditing experience

FDA regulatory knowledge

Job description

Integra LifeSciences Corporation is seeking a Lead Auditor, Quality Compliance to lead and coordinate corporate audits of the Quality Management System across multiple facilities and sites. The role requires strong knowledge of GMP/GDP, EU regulations, and regulatory expectations, with travel up to 50% internationally.

You will prepare audit reports, drive improvements, and coach sites toward higher quality standards while collaborating across departments and with external suppliers.