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:

• Auditing experience in medical device or pharmaceutical industries