Quality Engineer (Tijuana)

Quality Engineer (Tijuana)

22 ago
|
Biotix, Inc. - Mettler Toledo
|
Tijuana

22 ago

Biotix, Inc. - Mettler Toledo

Tijuana

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

Industry: Precision Instruments

Company: Mettler Toledo

Website:

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.

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📌 Quality Engineer (Tijuana)
🏢 Biotix, Inc. - Mettler Toledo
📍 Tijuana

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