Descripción y detalle de las actividades
The Quality Assurance Engineer will be responsible for supporting and maintaining the Quality Management System (QMS) in alignment with ISO ***** 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 ***** 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 *******, **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 ***** 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** Jornada completa
**Salario mensual neto** $1,000 - $1,002 MXN
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p.
viajar** No

📌 Medical Quality Assurance Engineer (Tijuana)
🏢 Luxshare
📍 Tijuana