Sustaining Quality Engineer

Tijuana Permanente View Job Description
We are looking for a Sustaining Quality Engineer responsible for ensuring the quality and regulatory compliance of existing products in the medical industry. The ideal candidate will lead quality problem resolution, change management, process validations, and ensure product compliance with relevant regulations throughout its life cycle.
  • Responsible for ensuring the quality and regulatory compliance
  • of existing products in the medical industry

Sobre nuestro cliente

International contract manufacturing company for medical products

Descripción

  • Support and ensure the quality of products already in the market.
  • Investigate and resolve quality issues for released products.
  • Manage Non-Conformance Reports (NCR) and lead Corrective and Preventive Actions (CAPA).
  • Lead process validations, including IQ, OQ, and PQ, for sustaining products.
  • Ensure compliance with regulatory standards (FDA, ISO 13485, etc.).
  • Manage product documentation updates (DHF, DMR, etc.) and handle Change Control processes (ECOs).
  • Collaborate with suppliers and customers to resolve quality-related issues.
  • Monitor product quality data and lead continuous improvement initiatives.



Perfil buscado

MUST

  • Bachelor's degree in Engineering, Quality, or related field.
  • 3+ years of experience in quality engineering and sustaining
  • Proven experience in the medical device industry.
  • Experience working in high-volume, high-paced manufacturing environments.
  • Strong knowledge of regulatory requirements (FDA, ISO 13485, PMDA, MDR, etc.) and quality management systems (QMS).
  • Experience with root cause analysis, CAPA, NCR and process validations.
  • Proficiency in statistical analysis tools (SPC, Minitab, etc.).
  • Excellent problem-solving and communication skills.
  • Hands-on, proactive approach.
  • Advanced English proficiency.
  • Location: Tijuana

Qué Ofrecemos

Competitive salary + benefits

Contacto
Laura Sánchez
Ingresar referencia para vacante
JN-022024-6342467

Descripción de la vacante

Sector
Ingeniería y manufactura
Sub Sector
Calidad
Industria
Industrial / Manufacturing
Localización
Tijuana
Tipo de contrato
Permanente
Nombre del consultor
Laura Sánchez
Referencia de la vacante
JN-022024-6342467
 

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