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 Integral 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
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Postúlate Si consideras que necesitas algún ajuste razonable para participar en la entrevista —por ejemplo, adaptar el espacio, el formato o los tiempos—, no dudes en informarlo con anticipación. Pedir un ajuste permite que el proceso sea más accesible e inclusivo para todas las personas. Lo importante es que puedas sentirte cómodo/a y mostrar tu mejor versión durante la entrevista.
Pregunta(s) de postulación:
- ¿Eres una persona con discapacidad? Ten en cuenta que este requisito es excluyente ya que en Incluyeme.com trabajamos para potenciar la empleabilidad de las personas con discapacidad