Darum lohnt es sich
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 elevate 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% Work Flexibility: Remote
What you will do:
Responsible for independently leading internal audits to assess compliance and effectiveness of the Quality Management System (QMS).
