Lead Auditor

Job Summary

A company is looking for a Lead Auditor.

Key Responsibilities

• Coordinate internal, external, and customer audits, ensuring action items are followed up and escalated as needed
• Align local and regional procedures with global processes to maintain high-quality standards
• Manage documentation related to quality certificates, audit reports, and other assigned records

Required Qualifications and Education

• Bachelor's degree or equivalent in Biology, Chemistry, Medical Technology, or a related field
• Qualified Lead Auditor with training and preferred certification from a recognized accreditation body
• 5 years of experience in a regulated industry or equivalent combination of education and experience
• Working knowledge of global regulations and standards such as 21 CFR and ISO 13485
• Experience with AI (Artificial Intelligence) is preferred