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%

Required Skill Profession

Business Operations Specialists

📌 Staff Internal Quality Auditor (Bogotá)
🏢 Stryker Professional Latin America, DE C.V.
📍 Bogotá