Staff Internal Quality Auditor

About the role

The Staff Internal Quality Auditor will independently lead internal audits to evaluate compliance and effectiveness of the Quality Management System (QMS) across sites. You will partner with site stakeholders to identify risks, drive continuous improvement, and support the global internal audit program.

Key responsibilities

• Plan, execute, report, and follow‑up on internal audits, tailoring scope and agenda to site inputs.
• Assess compliance with FDA, ISO 13485, MDR/MDD, and company procedures.
• Document audit findings, including non‑conformances and observations.
• Present audit results and insights to site leadership.
• Monitor audit observations, escalating trends or systemic risks.
• Interface with Site RAQA and Quality leadership teams.

Required profile

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

Required skills

• Internal auditing methodology.
• FDA regulatory requirements.
• ISO 13485 standard.
• MDR/MDD compliance.
• Audit planning, execution, and reporting.
• Quality Management System (QMS) assessment.