Staff Internal Quality Auditor

Incluyeme; Bogotá; Presencial; COP 65.000.000 - 105.000.000; Jornada completa

Descripción de la vacante

Incluyeme is seeking a qualified Internal Audit Lead to independently drive audits of the Quality Management System. You will partner with site stakeholders to drive compliance, identify risks, and support continuous improvement.

The role requires a Lead Auditor certification, fluent English and Spanish, and experience auditing in regulated industries, including FDA/ISO 13485 expectations. You will report to the RAQA and Quality leadership teams.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Bilingual EN/ES

Quality audits

Regulatory knowledge

Documentation

Educación

Bachelor’s degree in engineering/science/business

Descripción del empleo

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 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.