Staff Internal Quality Auditor

Job description

Work Flexibility: Remote 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 Travel Percentage: 40%