Lead Internal Auditor – Global Quality

About the role

The Lead Internal Auditor joins the Customer Quality & Compliance team to plan, lead and execute risk‑based internal audits across regulated medical device and pharmaceutical operations. Acting as a subject‑matter expert, you will ensure compliance with global regulations and drive continuous improvement of the Quality Management System.

Key responsibilities

• Lead and conduct risk‑based internal audits in line with the approved schedule, covering design, manufacturing, labs, post‑market surveillance and support processes.
• Serve as Lead Auditor for complex, cross‑functional, multi‑site audits, managing planning, execution, reporting and follow‑up.
• Assess QMS compliance against ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR and ICH requirements.
• Develop audit strategies, communicate findings, trends and improvement opportunities to stakeholders.
• Identify systemic issues and drive continuous‑improvement initiatives.
• Support inspection readiness activities, including preparation for regulatory authority inspections and Notified Body audits.

Required profile

• Bachelor’s degree in science, engineering or related field (advanced degree preferred).
• 8+ years experience in regulated quality systems, internal auditing or regulatory compliance within pharma/medical‑device industries.
• 5+ years experience as a Lead Internal Auditor; ISO 13485 Lead Auditor certification required.
• Strong analytical, risk‑based thinking and communication skills with ability to influence globally.
• Willingness to travel up to 50% globally; role may be remote or site‑based within the EU/UK.

Required skills

• ISO 13485 Lead Auditor certification
• ISO 9001
• FDA cGMP/QSR
• EU GMP
• IVDR
• ICH requirements
• Risk‑based auditing