Detalles del puesto

Validation Engineer Specialist (Healthcare)

Nuevo León   •   MXN35,000 - MXN45,000   •  Permanente

Bullet points

  • Responsible of all Validation activities for health care customers and NPI
  • Advanced English is requiered

Detalles del cliente

International contract manufacturer for the medical devices sector.

Descripción de la vacante

The main responsibilities are to:

  • Validate activities for health care customers, support the NPI process and helping to develop manufacturing and / or repair processes
  • Define and document the validation program for the site to support the product life cycle (IT, manufacturing process, machinery, etc)
  • Oversee key projects, processes and performance reports and data and analysis
  • Support a life cycle approach to validation (IOPQ, protocol/report generation, change control and records maintenance)
  • Implement and maintain the Validation Program for the site
  • Ensure that all documentation and records, electronic and hard copy, pertaining to validation are complete and in order
  • Write technical documents (Validation Master Plans, IOPQ, SOP's, Protocols, Reports, Out-of-Tolerance Reports, Investigations, Change Controls, etc.)
  • Review, recommend, and approve requirements specifications and verification methods, procedures, and results, which are communicated through requirement specifications, analysis, demonstration, inspection, test, and/or simulation results
  • Monitor and mitigate requirements of compliance risk
  • Provide independent oversight to validate that the product/system fulfills its intended use when placed in its intended environment (i.e., conforms to the customer's functional requirements; and meets the expected safety criteria, quality, and reliability standards)

Perfil del candidato

Bachelor's Degree in a Medical field, or an equivalent combination of education and experience. Master Degree is a plus. Experience in Healthcare segment is a must and strong knowledge in validation process (SAT, IQ, OQ, PQ). Experience working under health-care regulations such as ISO-13485. Experience in multiple validation disciplines including manufacturing process, hardware / software systems, equipment qualification, and facilities validation. Knowledge in verification and validation using risk based approach (S, D, and P-FMEAs, PHA, GD&T, etc.). Strong knowledge of medical devices requirements for regulatory purposes and global business environment. Advanced English is a must.

Oferta de empleo

  • Additional benefits

Aplicar para esta vacante

Si cumples con el perfil y experiencia profesionales requeridas puedes postularte haciendo click en el botón de Aplicar o a través de tu perfil de LinkedIn. El número de referencia para esta vacante es 31778. Tu CV será analizado por Roberta Belden.
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