Supplier Quality Engineer - Medical Devices & Compliance

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

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.