Supplier Quality Engineer

ICU Medical; Tijuana; Presencial; MXN 420.000 - 680.000; Jornada completa

Descripción de la vacante

ICU Medical is seeking a quality professional to own supplier quality metrics and drive continuous improvement in a medical device manufacturing environment. The role requires coordination across functions, audits when needed, and adherence to ISO 13485 and related systems.

The candidate should possess a university engineering degree, 3–5 years in a medical device setting, and strong English/Spanish communication skills for cross‑site collaboration and training initiatives.

Formación

• University degree in an engineering field required.
• 3–5 years in a similar role in the medical device manufacturing industry.
• ASQ Quality Engineering or SSGB preferred.
• Bilingual communication skills English/Spanish required.

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 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

Analytical problem solving

Communication skills

Coaching & technical writing

Cross-functional leadership

Bilingual English/Spanish

Reading drawings & GD&T

Statistical process control

Quality management systems ISO 13485

Supplier collaboration

Process control tooling

Educación

University degree in related engineering field

Herramientas

DIMENSIONS / GD&T reading

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