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Quality Sr. Manager - Medical Devices

Jalisco Permanente MXN140,000 - MXN170,000 por mes (MXN1,680,000 - MXN2,040,000 per year) Descripción de Vacante
Lead the Quality function for a medical device manufacturing site, ensuring regulatory compliance, operational excellence, and continuous improvement. This role will drive quality systems effectiveness, strengthen team accountability, lead digital transformation initiatives, and partner cross-functionally to enhance product quality, compliance, and business performance in a highly regulated environment.
  • QMS for Class II/III medical device manufacturing
  • Design Transfer, Validation, Supplier Quality, and FDA/ISO compliance.

Sobre nuestro cliente

International Medical Devices Manufacturer

Descripción

  • Lead the site Quality organization and serve as the primary representative for quality and regulatory matters.
  • Ensure compliance with FDA, cGMP, ISO, and other applicable global regulations.
  • Oversee and continuously improve the Quality Management System (QMS).
  • Drive quality strategy, operational excellence, and harmonization of quality processes across the organization.
  • Lead investigations, CAPA activities, quality metrics reviews, and risk mitigation initiatives.
  • Assess Quality team capabilities, identify organizational gaps, and implement development plans.
  • Champion the transition from manual processes to digital and AI-enabled quality solutions.
  • Promote a mindset of accountability, collaboration, and continuous improvement.
  • Partner with Manufacturing, Engineering, Supply Chain, and other stakeholders to improve business performance.
  • Drive budget adherence, cost-control initiatives, and sustainable quality improvements.



Perfil buscado

  • Bachelor's degree in Engineering, Science, or related technical field; advanced degree preferred.
  • 10+ years of Quality experience within Medical Devices and/or Pharmaceutical manufacturing.
  • 5+ years leading managers and multidisciplinary Quality teams.
  • Strong expertise in Class II/III medical device manufacturing processes, Design Transfer, Manufacturing Specifications, Supplier Qualification, Validation Strategy, and Production & Process Controls.
  • Extensive knowledge of FDA 21 CFR, cGMP, ISO 13485, and regulated manufacturing environments.
  • Demonstrated success leading organizational change and improving team performance.
  • Strong analytical, problem-solving, and root cause investigation skills.
  • Excellent communication, stakeholder management, and executive influencing capabilities.
  • Experience identifying quality gaps, solving market-impacting quality issues, and driving measurable operational improvements.



Qué Ofrecemos

Competitive Compensation Package

Contacto
Stefano Frausto
Ingresar referencia para vacante
JN-072026-7057292

Descripción de la vacante

Sector
Ingeniería y manufactura
Sub Sector
Calidad
Industria
Industrial / Manufacturing
Ubicación
Jalisco
Tipo de contrato
Permanente
Nombre del consultor
Stefano Frausto
Referencia de la vacante
JN-072026-7057292
 

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