23 ago
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Biotix, Inc. - Mettler Toledo
|
Centro-Norte
23 ago
Biotix, Inc. - Mettler Toledo
Centro-Norte
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.
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📌 Quality Engineer (Centro-Norte)
🏢 Biotix, Inc. - Mettler Toledo
📍 Centro-Norte