Descripción y detalle de las actividades

The functions and responsibilities mentioned in this document are illustrative but not limiting, for which the holder of this position will perform other functions and tasks related to his area of work that thus derive from the objectives and strategies of the area.
- 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 the ISO 13485 Quality Systems, Environmental Management System (ISO 14001), Occupational Health and Hygiene and Safety Management System (Ohsas 18001) and any other system that the company requires for its operation.




- Adhere to the ICU Medical code of conduct and dress.

Experiencia y requisitos
- 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 su

📌 Supplier Quality Engineer II (Tijuana)
🏢 Icu Medical
📍 Tijuana