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 Professional Latin America, DE C.V.
📍 Tijuana