Lead Auditor, Quality Compliance
Integra LifeSciences
full-time
Posted on:
Location Type: Office
Location: Tullamore • Ireland
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Job Level
Tech Stack
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP auditsGDP auditsGLP auditsGCP auditsauditing technical filesstatistical analysisregulatory compliancesterilizationmicrobiology
Soft Skills
leadershipcoordinationproblem-solvingcommunicationsupportfacilitation
Certifications
Formal Auditor certification