Ingeniero de Calidad Senior – Dispositivos Médicos, Lean

TACNA Services, Inc.; Tijuana; Hybrid; MXN 900,000 - 1,300,000; Full time

Job summary

TACNA Services, Inc. in Tijuana seeks a Senior Quality Engineer to represent quality on projects and provide overall quality support to production and operations, including implementing the Quality Management System.

The role requires 5–10 years in a regulated medical device environment, fluency in English and Spanish, and strong knowledge of QMS standards and risk management. Work is on-site in Tijuana with a focus on continuous improvement.

Qualifications

• B.S. in Engineering or Science or equivalent technical field.
• 5–10 years in Medical Device Manufacturing or other regulated industry.
• Fluent in English and Spanish.
• Working knowledge of QMS standards like ISO 13485 and ISO 14971.
• Working knowledge of statistical techniques.
• Strong written and verbal communication and documentation skills.

Responsibilities

• Represent quality on projects and support production and operations with QMS implementation.
• Participate in compliance with FDA QSRs, ISO 13485, ISO 14971.
• Review and execute process verifications and validations (IQ/OQ/PQ).
• Assist in creating and updating manufacturing procedures and work instructions.
• Support risk management activities related to manufacturing processes.
• Investigate non-conforming material and identify improvement opportunities.
• Assist supplier audits, manufacturing validation, and proposed changes.
• Perform internal audits and assist in hosting external audits.

Skills

Quality engineering

Regulated industry experience

Bilingual English/Spanish

Statistics knowledge

QMS ISO 13485 familiarity

ISO 14971 risk management

Lean/Kaizen

Documentation & communication

Education

B.S. in Engineering or Science

Tools

Excel

Databases

Word processing

Job description

TACNA Services, Inc. in Tijuana seeks a Senior Quality Engineer to represent quality on projects and provide overall quality support to production and operations, including implementing the Quality Management System.

The role requires 5–10 years in a regulated medical device environment, fluency in English and Spanish, and strong knowledge of QMS standards and risk management. Work is on-site in Tijuana with a focus on continuous improvement.