Lead Auditor, Quality Compliance

About the role

The Lead Auditor, Quality Compliance joins the Corporate Audit team to lead, coordinate and perform corporate audits of the Quality Management System across Integra LifeSciences' design, manufacturing and distribution facilities. This role ensures global QMS policies, standards and regulatory requirements are consistently applied.

Key responsibilities

• Conduct evidence‑based investigations to verify compliance with global QMS policies, regulatory and legislative requirements.
• Prepare formal audit reports for the head of the audit program, including observations, recommendations, site classification and executive summaries for senior leaders.
• Identify problematic areas during audits and provide assistance, suggestions and recommendations to achieve desired improvements.
• Support site inspection readiness through formal audits, high‑risk CAPA reviews, mock inspections and coaching.
• Collaborate with the head of the audit program to improve audit efficiency and efficacy while maintaining quality control.
• Facilitate global implementation of policies through auditing, education, communication and enforcement.

Required profile

• Minimum 15 years of experience auditing GMP, GDP, GLP or GCP environments in medical device or pharmaceutical manufacturing.
• Bachelor’s degree in engineering, sciences or a related technical field; Master’s degree preferred.
• Formal auditor certification (e.g., IRCA, ASQ CQA, BSI, Exemplar Global).
• Experience with 21 CFR Part 820, ISO 13485, EU Medical Device Regulation, MDSAP and ISO 14971.
• Proven ability to lead audits of suppliers, manufacturing sites, distribution centers or laboratories.

Required skills

• GMP, GDP, GLP, GCP auditing
• 21 CFR Part 820, ISO 13485, EU MDR, MDSAP compliance
• ISO 14971 risk management
• Audit certification (IRCA, ASQ CQA, BSI)
• Sterilization, microbiology, manufacturing facility engineering
• Statistical analysis, process validation, regulatory compliance
• Clinical trials, computer systems validation, quality systems, data security