Quality Engineer

Biotix, Inc. - Mettler Toledo; Tijuana; Presencial; MXN 240.000 - 360.000; Jornada completa

Descripción de la vacante

Mettler Toledo in Tijuana seeks a Quality Engineer to support implementation and monitoring of quality systems to ensure compliance with ISO standards and regulatory requirements. You will work with cross-functional teams to address quality issues and drive continuous improvement.

The role involves developing and maintaining control plans, participating in audits, and reporting quality metrics such as PPM, yield, and scrap. English proficiency is required.

Formación

• Bachelor’s degree in Industrial, Mechanical, Electronic, Biomedical Engineering or related field.
• Intermediate to advanced English proficiency (ability to read technical documentation, write reports, and participate in meetings)

Responsabilidades

• Support the development, implementation, and maintenance of product and process control plans.
• Investigate and support resolution of quality issues using structured problem-solving methodologies (root cause analysis, CAPA).
• Participate in internal and external audits and assist with corrective action implementation.
• Collaborate with manufacturing, engineering, logistics, and customer service to ensure quality requirements are met.
• Support process validations, engineering changes, product transfers, and new product introductions.
• Collect, analyze, and report quality performance metrics (PPM, yield, scrap, complaints, etc.).
• Assist in maintaining quality documentation including procedures, work instructions, and technical records.
• Support interactions with suppliers and customers regarding quality issues and improvement actions.
• Ensure compliance with applicable standards and regulations (ISO 9001, ISO 13485, FDA, etc.).

Conocimientos

FMEA

SPC

MSA

8D

5 Whys

Ishikawa

ERP systems

Minitab

Excel (advanced)

Analytical thinking

Educación

Bachelor’s degree in Industrial, Mechanical, Electronic, Biomedical Engineering or related field

Herramientas

ERP systems

Minitab

Advanced Excel

Descripción del empleo

Location: Parque Sur, Blvd 2000, El Realito, Tijuana

Industry: Precision Instruments

Company: Mettler Toledo

Website: https://www.mt.com/int/en/home.html

POSITION SUMMARY

Supports the implementation, monitoring, and improvement of quality systems and processes to ensure compliance with internal standards, regulatory requirements, and customer expectations. Works closely with cross-functional teams to address quality issues, support improvement initiatives, and maintain product and process compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Support the development, implementation, and maintenance of product and process control plans.
• Investigate and support resolution of quality issues using structured problem-solving methodologies (root cause analysis, CAPA).
• Participate in internal and external audits and assist with corrective action implementation.
• Collaborate with manufacturing, engineering, logistics, and customer service to ensure quality requirements are met.
• Support process validations, engineering changes, product transfers, and new product introductions.
• Collect, analyze, and report quality performance metrics (PPM, yield, scrap, complaints, etc.).
• Assist in maintaining quality documentation including procedures, work instructions, and technical records.
• Support interactions with suppliers and customers regarding quality issues and improvement actions.
• Ensure compliance with applicable standards and regulations (ISO 9001, ISO 13485, FDA, etc.).

QUALIFICATIONS

• Bachelor’s degree in Industrial, Mechanical, Electronic, Biomedical Engineering or related field.
• Intermediate to advanced English proficiency (ability to read technical documentation, write reports, and participate in work meetings)

EXPERIENCE SUMMARY

• 2–4 years of experience in quality engineering or related roles within manufacturing or regulated industries.
• Experience applying quality tools to analyze and resolve product or process quality issues

SKILLS AND COMPETENCIES

Technical Skills (Hard Skills)

• Working knowledge of quality standards and regulations (ISO 9001, ISO 13485, 21 CFR Part 820).
• Familiarity with quality tools such as FMEA, SPC, MSA, 8D, 5 Whys, and Ishikawa.
• Ability to read and interpret technical drawings, specifications, and process documentation.
• Experience using ERP systems and statistical tools such as Minitab or advanced Excel.
• Understanding of validation concepts (IQ/OQ/PQ), auditing principles, and quality documentation.

Soft Skills

• Analytical thinking and structured problem-solving.
• Effective communication with cross-functional teams.
• Ability to manage multiple tasks and priorities.
• Attention to detail and commitment to quality.
• Continuous improvement mindset.