Staff Internal Quality Auditor

Hace 7 días

Bogotá, Bogotá, Distrito Capital, Colombia Incluyeme Jornada completa $ 65 - $ 105 Por obra

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.