Sr Quality Engineer

Biotix International, S. de R.L. de C.V.; Tijuana; Presencial; USD 35,000 - 55,000; Jornada completa

Descripción de la vacante

A leading company in precision instruments is seeking a Quality Manager to lead the implementation and improvement of quality systems. The role involves overseeing quality control activities, managing audits, and ensuring compliance with regulatory standards, while mentoring junior engineers. Ideal candidates will have a Bachelor's degree in Engineering and over 5 years of relevant experience.

Formación

• 5+ years of experience in quality roles within manufacturing or regulated industries.
• Proven experience leading improvement projects and resolving complex quality issues.

Responsabilidades

• Develop, implement, and improve product and process control plans.
• Lead investigation and resolution of complex quality problems.
• Manage internal and external audits; coordinate corrective actions.

Conocimientos

Quality standards knowledge

Problem-solving

Technical leadership

Effective communication

Project management

Educación

Bachelor’s degree in Engineering

Herramientas

ERP

MES

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

SUMMARY:Leads the implementation, monitoring, and continuous improvement of quality systems and processes to ensure compliance with internal standards, regulatory requirements, and customer satisfaction. Oversees quality control activities, resolves complex issues, and drives improvement projects across operations.

MAIN RESPONSIBILITIES:

·Develop, implement, and improve product and process control plans.

·Lead investigation and resolution of complex quality problems (root cause analysis, CAPA).

·Manage internal and external audits; coordinate corrective actions from findings.

·Support manufacturing, engineering, logistics, and customer service to ensure quality requirements are met.

·Participate in process validations, engineering changes, product transfers, and new product launches.

·Prepare and present quality performance reports (PPM, yield, scrap, complaints, etc.).

·Coordinate work of junior engineers and technicians; provide technical mentorship.

·Interface with customers and suppliers regarding quality issues, complaints, and improvement initiatives.

·Ensure compliance with applicable standards and regulations (ISO 9001, ISO 13485, FDA, etc.).

QUALITIFICATIONS:

· Bachelor’s degree in industrial, Mechanical, Electronic, Biomedical Engineering or related field.

EXPERIENCE SUMMARY:

·5+ years of experience in quality roles within manufacturing or regulated industries.

·Proven experience leading improvement projects and resolving complex quality issues.

SKILLS AND COMPETENCIES:

·Technical Skills (Hard Skills):

• Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, 21 CFR Part 820).
• Proficient with quality tools: FMEA, SPC, MSA, 8D, 5 Whys, Ishikawa.
• Ability to read and interpret technical drawings and product specifications.
• Experience with ERP, MES, and statistical tools (Minitab, advanced Excel).
• Solid understanding of validations (IQ/OQ/PQ), auditing, and technical documentation.

·Soft Skills:

• Technical leadership and mentoring capabilities.
• Strong problem-solving and decision-making skills.
• Effective communication with cross-functional teams.
• Results-driven with a focus on continuous improvement.
• Project management and prioritization.