Job Description
What you will do
- 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
- ...