Medical Quality Assurance Engineer

hace 4 semanas

Tijuana, México LUXSHARE A tiempo completo

Descripción y detalle de las actividadesThe Quality Assurance Engineer will be responsible for supporting and maintaining the Quality Management System (QMS) in alignment with ISO 13485 and other applicable standards, ensuring compliance with both regulatory and customer-specific requirements in the medical device industry.This role is essential for maintaining product quality across the lifecycle, preparing for and supporting audits, and driving continuous improvement initiatives. The engineer will collaborate with internal teams and external bodies to uphold Luxshare’s commitment to quality and compliance.This position is critical for the business due to the following reasons:- Ensure compliance with the Quality Management System, in accordance with Luxshare QMS, applicable standards, for example ISO 13485 and FDA 21 CFR Part 820 and Other medical standards.- Assist in the development, implementation, and improvement of quality procedures, work instructions, and forms.- Perform internal audits, manage CAPA processes, and support external audits or inspections (e.g., notified bodies, FDA, customers).- Carry out inspections and/or tests of products, raw materials, equipment or accessories according to established specifications using special test equipment including where necessary development of test equipment specifications and protocols.- Reviews and investigates product problems and/or customer complaints or other nonconformities, including evaluating the quality system; determination of root cause and recommend corrective and preventive actions where required (complaints, CAPAs and NCRs).- Ensure documentation control, change control, and other records are up to date and compliant.- Monitor and report on quality metrics, trends, and key performance indicators.- Support in the administration of new revised methods when required.- Promote a culture regulatory compliance.Experiência y requisitos**Skills**Bachelor’s Degree is required (Engineering, Quality, or related field).Minimum **3 -5 years** of experience in quality assurance in the medical device industry.Strong knowledge of **ISO 13485**, **FDA 21 CFR Part 820**, and other Medical regulatory standards.Experience with **CAPA, non-conformance investigations, audits**, and QMS tools.Good command of Microsoft Office.Independent, proactive, and able to work with little supervision and operate in a team environment.Ability to work effectively with remote, distributed teams.Time-management skills.Ability to build strong relationships.variation, assess capability, and drive improvements (Core tools).Advance English language skills, both verbal and written.**Certified Quality Engineer (CQE)** or **ISO 13485 Lead/ Internal Auditor**certification is a plus.Beneficios- Beneficios de acuerdo a la LFT- Seguro de vida- Fondo de ahorro- Seguro de gastos médicos- Bonos anuales- Plan de indexación- Utilidades garantizadas- Descuentos de productos- Servicios medicos en planta- Comedor- Prestaciones superiores a ley**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Salario mensual neto** $1,000 - $1,002 MXN**Estudios** Carrera con título profesional**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p. viajar** No

  • Quality Engineer

    hace 4 semanas

    Tijuana, México Carlisle Medical Technologies A tiempo completo

    Descripción y detalle de las actividadesQuality Engineer I is responsible for ensuring the safety and quality of our products and procedures through rigorous inspections, implementation of quality control measures, and identification of areas for improvement, collaborates with cross-functional teams to address quality issues, drive continuous improvement,...

  • Sr Quality Engineer

    hace 22 horas

    Tijuana, México ICU Medical A tiempo completo

    The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Sr. Quality Engineer will provide quality assurance...

  • Senior Quality Engineer, Design

    hace 1 semana

    Tijuana, México ICU Medical A tiempo completo

    Direct message the job poster from ICU Medical Human Resources Professional, SHRM-CP, HRBP Position Summary Provide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and...

  • Senior Quality Engineer, Design

    hace 1 semana

    Tijuana, México ICU Medical A tiempo completo

    Direct message the job poster from ICU MedicalHuman Resources Professional, SHRM-CP, HRBPPosition SummaryProvide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and...

  • Senior Quality Engineer, Design

    hace 1 semana

    Tijuana, México ICU Medical A tiempo completo

    Direct message the job poster from ICU MedicalHuman Resources Professional, SHRM-CP, HRBPPosition SummaryProvide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and...

  • Electrical Test Engineer

    hace 3 días

    Tijuana, México Carlisle Medical Technologies A tiempo completo

    Descripción y detalle de las actividades Capability to design and develop custom test adapters and programs allows for more thorough and tailored testing of the medical cables. This ensures that the products meet specific requirements and standards, which is crucial for medical devices. Efficient testing processes developed by a competent Test Engineer can...

  • Electrical Test Engineer

    hace 3 días

    Tijuana, México Carlisle Medical Technologies A tiempo completo

    Descripción y detalle de las actividades Capability to design and develop custom test adapters and programs allows for more thorough and tailored testing of the medical cables. This ensures that the products meet specific requirements and standards, which is crucial for medical devices. Efficient testing processes developed by a competent Test Engineer can...

  • Electrical Test Engineer

    hace 3 días

    Tijuana, México Carlisle Medical Technologies A tiempo completo

    Descripción y detalle de las actividades Capability to design and develop custom test adapters and programs allows for more thorough and tailored testing of the medical cables. This ensures that the products meet specific requirements and standards, which is crucial for medical devices. Efficient testing processes developed by a competent Test Engineer can...

  • Electrical Test Engineer

    hace 2 semanas

    Tijuana, México Carlisle Medical Technologies A tiempo completo

    Descripción y detalle de las actividades Capability to design and develop custom test adapters and programs allows for more thorough and tailored testing of the medical cables. This ensures that the products meet specific requirements and standards, which is crucial for medical devices. Efficient testing processes developed by a competent Test Engineer...

  • Senior Quality Engineer, Design

    hace 3 días

    Tijuana, Baja California, México ICU Medical A tiempo completo

    Position SummaryProvide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other...