ISO 13485 Lead Auditor

A company is looking for an ISO 13485 Lead Auditor.

Key Responsibilities :

Manage audit projects, including planning, execution, and reporting within set timelines

Provide client support with a focus on both auditing and mentoring

Identify and assist in developing necessary training modules for the Audit Practice

Required Qualifications :

Professional and qualified Medical Device ISO 13485 Lead Auditor with extensive experience

Experience with MDSAP auditing

Familiarity with FDA 21 CFR Part 820

Strong auditing experience in the Medical Device industry