About the role

  • Lead Auditor for Quality Compliance at Integra LifeSciences, conducting audits across various facilities in Ireland. Ensuring compliance with quality standards and regulations in medical devices sector.

Responsibilities

  • Lead, coordinate and perform corporate audits of the Quality Management System
  • Supply formal reports to the head of the audit program on site audits
  • Identify problematic areas during audits and assist with improvements
  • Support site inspection readiness through audits and informal reviews
  • Facilitate Global implementation of policies and clear application of auditing processes
  • Lead necessary corporate audits and work with Site Quality Representatives
  • Recommend additional work required with audited sites and participate in quality initiatives
  • Provide review and support to individuals or locations within the company

Requirements

  • Experience with Corporate, divisional, site, supplier GMP, GDP, GLP or GCP audits
  • Related quality/operations GMP work experience in medical devices or pharmaceutical sector
  • Experience auditing technical files for conformance with EU regulations
  • Experience working for regulatory agencies or Notified Bodies preferred
  • Experience in sterilization, microbiology, statistical analysis, regulatory compliance, etc.
  • A working knowledge of different languages and willingness to travel widely
  • Bachelor’s degree in engineering, or sciences or relevant technical field required
  • Master’s degree preferred
  • Formal Auditor certification by a recognized body
  • Minimum 15 years of experience in auditing

Benefits

  • Health insurance
  • Career development opportunities
  • Paid time off

Job title

Lead Auditor, Quality Compliance

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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