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Weekend Quality Assurance Specialist

hace 2 meses

Tijuana, Baja California, México Mam De La Frontera, S.A. De C.V. A tiempo completo

Job Summary

Mam De La Frontera, S.A. De C.V. is seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team on a weekend shift. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our respiratory therapy devices and participating in the execution of quality functions in compliance with FDA QSRs, ISO 13485, and ISO 14971.

Key Responsibilities:

  • Participate in the execution of quality functions in compliance with FDA QSRs, ISO 13485, and ISO 14971.
  • Execute quality engineering functions according to ISO 1485, FDA, and QSR.
  • Support risk management activities, including PFMEA.
  • Support incoming inspections, update procedures, forms, methods, and training.
  • Develop and maintain quality documentation, including procedures, work instructions, and manufacturing procedures.
  • Investigate non-conforming material and implement corrective actions.

Requirements:

  • 1-3 years of experience in medical device manufacturing as a quality engineer.
  • Working knowledge of QMS standards, including ISO 13485, and familiarity with risk standards, such as ISO 14971.
  • English proficiency (80%).
  • Statistical techniques and advanced Excel skills.

What We Offer:

  • A competitive salary of $1700 - $1900 MXN per month.
  • A permanent contract with a weekend shift schedule.
  • A dynamic and growing company with opportunities for professional development.