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 General 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%

📌 Staff Internal Quality Auditor (Tijuana)
🏢 Stryker
📍 Tijuana