Medical Device Supplier Quality Engineer II

ICU Medical; Tijuana; Presencial; MXN 350.000 - 550.000; Jornada completa

Descripción de la vacante

ICU Medical is seeking a dedicated Supplier Quality Engineer in Baja California, Mexico. The role focuses on owning supplier quality metrics, conducting supplier audits when needed, and training teams in root cause analysis tools to ensure compliance with ISO 13485 and related standards.

The ideal candidate will have 3–5 years in the medical industry, strong communication and technical writing skills, and the ability to lead cross-functional projects while working closely with suppliers to drive

Formación

• Degree completed in Electrical, Mechanical, Engineering or equivalent.
• 3-5 years of professional experience in the medical industry, or a closely related sector, is required.
• ASQ Quality Engineering, Certified Auditor (preferred), SSGB certifications preferred.
• Communication and human relations skills including coaching skills and technical writing.
• Ability to analyze and solve problems.
• Knowledge of reading plans DIMENSIONS and geometric tolerances.
• General knowledge of the statistical control process, and measurement and analysis systems.
• Basic knowledge of the FDA Quality System Standard ISO 13485.
• Ability to plan and carry out effective meetings and group presentations.
• Ability to coordinate and lead cross-functional projects and team activities effectively and efficiently.
• Ability to work closely with suppliers to ensure quality improvement.
• Ability to design and implement tools and mixtures to improve process control.
• Advanced level of English.

Responsabilidades

• Supplier audits (if necessary)
• Owner of the process of quality metrics to the supplier.
• Provider training in root cause analysis tools.
• Evaluation of the quality of the articles related to validations derived from repairs, new products, materials, changes in the supplier's processes or molds (AQA).
• Follow up on supplier change requests (SCR).
• Investigations of provider-related complaints
• Verification of the supplier's effective corrective actions and reduction of repetitive problems.
• Know and apply the policies and procedures of ISO 13485, ISO 14001, Ohsas 18001 and any other system required by the company.
• Adhere to the ICU Medical code of conduct and dress.

Conocimientos

Analytical skills

Problem solving

Communication skills

Technical writing

Coaching skills

Team coordination

English proficiency

Educación

Bachelor's degree in Electrical/Mechanical Engineering or equivalent

Herramientas

ASQ Quality Engineer

Certified Auditor

SSGB certification

Descripción del empleo

ICU Medical is seeking a dedicated Supplier Quality Engineer in Baja California, Mexico. The role focuses on owning supplier quality metrics, conducting supplier audits when needed, and training teams in root cause analysis tools to ensure compliance with ISO 13485 and related standards.

The ideal candidate will have 3–5 years in the medical industry, strong communication and technical writing skills, and the ability to lead cross-functional projects while working closely with suppliers to drive