What you will do:

Responsible for independently leading internal audits to assess compliance and effectiveness of the Quality Management System (QMS). Partners with site stakeholders to drive compliance, identify risks, and support continuous improvement.

Lead internal audits from planning through execution, reporting, and follow-up
Develop and tailor audit scope, agenda, and plans based on site inputs
Assess compliance to FDA, ISO 13485, MDR/MDD, and company procedures
Document audit results, including nonconformances and observations
Present audit results and insights to site leadership
Support execution of the Global Internal Audit Program
Monitor audit observations and escalate trends or systemic risks
Interface with Site RAQA and Quality leadership teams

What you need:

Required:

Bachelor’s degree in engineering, science, business administration or related field.
Certified Lead Auditor (or equivalent quality auditing certification) required
At least 2 years of experience auditing in a regulated industry
Fluent in both English and Spanish required
Working knowledge of FDA and ISO 13485 requirements

Preferred: