Supplier Quality Engineer

ICU Medical; Tijuana; Presencial; MXN 420.000 - 700.000; Jornada completa

Descripción de la vacante

ICU Medical in Mexico (Tijuana) is seeking a Quality Engineer focused on supplier quality assurance. You will lead supplier audits, own quality metrics for suppliers, and train on root cause analysis tools to drive continuous improvement.

The role requires a university engineering degree and 3-5 years in the medical device manufacturing industry, with ASQ/SSGB preferred. Strong knowledge of ISO 13485 and cross-functional collaboration is essential.

Formación

• University Degree completed in related Engineering field is required.
• 3-5 years experience in similar role in the medical device manufacturing industry 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.
• Strong Knowledge of reading plans DIMENSIONS and geometric tolerances.
• Strong knowledge of the statistical control process, and measurement and analysis systems.
• knowledge of the FDA Quality System Standard ISO 13485.
• Ability to plan and carry out effective meetings and group presentations in Spanish/English.
• 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 to improve process control.
• Advanced level of bilingual communication skills English/Spanish

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 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, ethics and dress.

Conocimientos

Quality audits

Supplier management

Root cause analysis

Statistical analysis

Dimensional tolerances

Coaching skills

Technical writing

Bilingual EN/ES

Educación

Engineering degree

Descripción del empleo

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.

Duties and responsibilities

• 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, ethics and dress.

Minimum education and experience

• University Degree completed in related Engineering field is required.
• 3-5 years experience in similar role in the medical device manufacturing industry 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.
• Strong Knowledge of reading plans DIMENSIONS and geometric tolerances.
• Strong knowledge of the statistical control process, and measurement and analysis systems.
• knowledge of the FDA Quality System Standard ISO 13485.
• Ability to plan and carry out effective meetings and group presentations in Spanish/English.
• 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 to improve process control.
• Advanced level of bilingual communication skills English/Spanish