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HologicPosted 1 month ago

Documentation Assistant CR (L-S 2pm a 10pm)

On-siteAlajuela, Alajuela Province, Costa Rica

Full TimeLargeHealthcare Tech

Job Summary

Monitor quality requirements and production standards to ensure products meet regulatory benchmarks. Review documentation for DHRs, verify sterile loads against procedures, and authorize product releases as the designated management representative. Check Agile for non-conformities, store DHRs per protocol, and generate NCEs while segregating defective materials. Support improvement, NPI, and VIP projects; maintain communication with Supply Chain, production, and microbiology teams. Standardize work procedures, train staff on documentation best practices, and update traceability reports. Requires ISO 13485 knowledge, Agile/Oracle proficiency, and Spanish/English basics.

Required Qualifications

  • Noveno año aprobado(Equivalente a primaria completa y 3 de años en puesto de similar naturaleza) o equivalente a 2 años de experiencia en puestos similares
  • Experiencia de al menos 1 año en puestos de similar naturaleza
  • Español/inglés básico

Desired Qualifications

  • Normas ISO 13485:2003, FDA, aseguramiento de la calidad, procesos productivos y conocimiento en los programas Oracle y Agile
  • Internet: Si
  • Correo Electrónico: Si
  • Otras Herramientas: Agile y Oracle, conocimiento en la elaboración de órdenes de cambio de documentos del sistema de calidad

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