Descripción y detalle de las actividades
The Quality Engineer I position supports quality assurance activities to ensure compliance with applicable regulatory standards (such as FDA and ISO *****) and internal quality systems.
This entry-level role focuses on collaborating on quality projects, process improvements, and data analysis to maintain and optimize product quality throughout its manufacturing lifecycle.
- Reviews and investigates product issues and/or customer complaints or other nonconformities, including quality system assessments, root cause determinations, and recommends corrective and preventive actions where required.
- Provides quality support for products and project development.
- Acts as a quality representative for quality issues in transfer products.
- Conduct routine walkthroughs (Gemba) in manufacturing areas to identify opportunities for improvement.
- Provide feedback to manufacturing engineering to reduce rejects and non-conforming materials.
- Ensure that documentation and processes comply with GMPs, GDPs, and applicable regulatory requirements.
- Formulate, analyze, and present statistical data reports on registrations and tests developed by your CFT.
- Provide support and assistance in manufacturing process validations at your CFT.
- Perform inspections and/or tests of products, raw materials, equipment, or accessories according to established specifications using special test equipment, including, where necessary,



the development of test equipment specifications and protocols.
- Participate in your CFT's mandatory meetings, Tier 2 meetings, and weekly meetings, and prepare and present information and documentation associated with Quality engineering activities.
- Assist in the administration of new revised methods when required.
- Execute and comply with the specific activities and requirements outlined in the documented quality system.
Experiência y requisitos
- University degree in Engineering (Industrial, Biomedical, Chemical, or related field)
- 1 to 3 years of experience in quality assurance or engineering in the manufacturing industry.
- Experience with FDA regulations for medical products.
- Excellent oral and written communication skills.
- Bilingual English/Spanish.
- Knowledge of drawing interpretation, statistics, and data analysis.
- Ability to follow written instructions without special supervision.
Incentivos
- Beneficios de acuerdo a la LFT
- Seguro de vida
- Fondo de ahorro
- Seguro de gastos médicos
- Caja de ahorro
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p.
viajar** Si

📌 Quality Engineer I (Tijuana)
🏢 ICU Medical
📍 Tijuana