Analista De Calidad Y Asuntos Regulatorios (cdmx) (bogotá)

Smith & Nephew

Mexico City, Mexico
Hybrid
Quality management system implementation
Regulatory compliance for medical devices
Product complaint management
Smith & Nephew is seeking an Analista De Calidad Y Asuntos Regulatorios to enhance the quality management system and ensure regulatory compliance in the medical device sector. The ideal candidate will have experience in quality management and a relevant educational background, contributing to both local and global quality initiatives

Job Summary

  • This position is responsible for implementing, maintaining, and continuously improving the Quality Management System at Smith + Nephew Mexico, ensuring compliance with local regulations and global standards.
  • Key responsibilities include managing product complaints, supporting field actions, coordinating continuous improvement processes, and ensuring compliance with local and international regulations like ISO 13485:2016 and ISO 9001:2015.
  • The role offers benefits such as life, medical, and dental insurance, savings funds, grocery vouchers, and access to unlimited learning tools.

Matching Summary

Match Score: 80

Smith & Nephew is seeking an Analista De Calidad Y Asuntos Regulatorios to enhance the quality management system and ensure regulatory compliance in the medical device sector. The ideal candidate will have experience in quality management and a relevant educational background, contributing to both local and global quality initiatives.

Skills & Requirements

Must-have

  • Quality Management System implementation
  • Regulatory compliance for medical devices
  • Product Complaint Management
  • CAPA and NCR process management
  • Supplier evaluation and auditing

Nice-to-have

  • Continuous improvement initiatives
  • Cross-functional collaboration
  • Attention to detail and organization

Key Requirements

  • Minimum 2 years of experience in a similar role
  • Bachelor's degree in Health Sciences or related field
  • Intermediate English proficiency
  • Reside in Mexico (CDMX) or Bogotá

Work Rights

Not specified

Tailored Resume

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