Empleos de fda en Tijuana

Outset Medical, Inc. is seeking a Quality Systems Specialist to support and enhance the Quality Management System (QMS) globally, with emphasis on ISO-13485 and FDA 21 CFR 820 compliance. This role collaborates with Engineering, Manufacturing, and Quality teams to drive CAPA, training, and metrics.The ideal candidate has a Bachelor’s degree in a relevant...

North American Production Sharing, Inc. in Tijuana is seeking a Quality Specialist to evaluate, maintain, and improve the Quality Systems at our facility.The role focuses on NCMRs, CAPA, COR, and manufacturing deviations to ensure compliance with global regulatory standards. Responsibilities include master data like MVP and part-number generation,...

A pioneering medical device company in Tijuana is seeking an experienced Android Software Engineer to enhance their innovative Tablo™ system. The role includes developing high-complexity user interfaces and collaborating with clinical experts to define requirements. Ideal candidates should have a strong background in Android development, including...

North American Production Sharing, Inc. in Tijuana, Mexico is seeking a Production QA Engineer to evaluate, maintain, and improve Quality Systems at the plant, including NCMRs, CAPA, and Change Control.The role focuses on part number generation, MVP maintenance, regulatory compliance with ISO 13485, 21 CFR Part 820, COFEPRIS, and supports regulatory...

Grupo TECMA in Mexico seeks a seasoned Quality & Regulatory Compliance professional to own and maintain the QMS, lead FDA and ISO audits, and drive CAPA and risk management programs. You will collaborate across Manufacturing Engineering, Quality, Supply Chain, and Operations to embed compliance in daily operations.The role requires deep regulatory knowledge...

Grupo TECMA is seeking a senior Quality & Regulatory Compliance leader to own the site QMS and ensure alignment with FDA QMSR and ISO 13485 in Tijuana. You will lead audits (FDA, ISO, customer) and drive CAPA, risk management, and change control while coordinating with Manufacturing, Quality, and Supply Chain to embed compliance into daily operations and...

Quality & Regulatory ComplianceOwn and maintain the site Quality Management System (QMS) in alignment with:FDA QMSR (21 CFR 820 - ISO 13485:2016 aligned)ISO 13485 and applicable global regulationsMonitor and implement regulatory updates (FDA, ISO, international) and translate them into actionable site requirements.Ensure QMS documentation is current,...

Quality & Regulatory ComplianceOwn and maintain the site Quality Management System (QMS) in alignment with:FDA QMSR (21 CFR 820 - ISO 13485:2016 aligned)ISO 13485 and applicable global regulationsMonitor and implement regulatory updates (FDA, ISO, international) and translate them into actionable site requirements.Ensure QMS documentation is current,...

Fresenius Medical Care busca técnico de mantenimiento manufactura para asegurar condiciones seguras y eficientes en líneas de producción. Se requiere experiencia en diagnóstico de fallas y mantenimiento programado, con base en GMP, QSR y FDA, y capacidad para elaborar planos y reportes.El rol implica coordinar mantenimientos, proponer mejoras y capacitar...

Mam de la Frontera, S.A. de C.V. busca un responsable de calidad en planta para dar seguimiento a lineamientos y procedimientos de fabricación, inspección y empaque de productos médicos. Deberá gestionar la documentación ante FDA/ISO y liderar iniciativas de validación de productos y procesos. El candidato deberá manejar indicadores de calidad,...

Avent, S. de R.L. de C.V. busca un/a Supervisor/a de Calidad para coordinar al personal de producción y garantizar el cumplimiento de QSR e ISO 13485. Se requiere título profesional y al menos 3 años de experiencia en GMP, manufactura, ensamble y empaque de dispositivos médicos.Entre las funciones: supervisar y entrenar al personal, analizar problemas de...

Foxconn Baja California, S.A. de C.V. busca profesional en Calidad para asegurar la implementación y cumplimiento de sistemas, validaciones y requerimientos regulatorios en la manufactura de dispositivos médicos.El rol lidera CAPA, no conformidades y auditorías internas y externas, analizando datos de calidad para identificar tendencias y oportunidades....

Foxconn Baja California, S.A. de C.V. busca un líder de Ingeniería de Manufactura para dirigir estrategias y procesos en dispositivos médicos, asegurando eficiencia y cumplimiento con normativas como ISO 13485, FDA y GMP.Se requiere experiencia de 5+ años en puestos de liderazgo en manufactura y conocimiento en transferencias tecnológicas, validación...

Merit Medical in Mexico (Tijuana) seeks an experienced Regulatory Affairs professional to align regulatory goals with the company’s strategic priorities. You will collaborate with Marketing, R&D, Operations and Quality Assurance to ensure global submissions meet evolving requirements.The role demands strong knowledge of medical device regulations and...

Haemonetics seeks an experienced engineer to lead assembly processes (harness, bag making, bowl assembly) and drive project management from concept through production. You will advance preventive maintenance, CI programs, and budget planning to maximize equipment life and product quality.The role requires +5 years in engineering with ultrasonic welding...

Dirigir la estrategia integral de mantenimiento del área médica, asegurando la disponibilidad, confiabilidad y eficiencia de los equipos e instalaciones, así como el cumplimiento de los requerimientos regulatorios aplicables a la manufactura de dispositivos médicos. Diseñar y ejecutar estrategias de mantenimiento preventivo, correctivo y predictivo,...

Amphenol CMT - Critical Medical Technologies in Tijuana seeks a hands‑on manufacturing engineer to develop, implement, and optimize processes that enhance efficiency and product quality. You will collaborate with cross‑functional teams and drive process improvements across the production floor.Requirements include an engineering degree with 3+ years of...

Integer is seeking an engineer to support the software development lifecycle for medical device software, applying engineering methods and tools to meet customer expectations with guidance from senior staff.You will work with quality and regulatory requirements, including QMS and FDA-related guidelines, and participate in projects that develop new product...

Oferta confidencial in Mexico is seeking a Quality Assurance professional to analyze customer data, audit materials and processes, and maintain GMP/ISO13485 standards across manufacturing.The role includes supporting QMS documentation, local and global CAPA activities, KPI monitoring, audits, change control, and training to ensure product conformance and...

Liderar la estrategia de ingeniería y el desarrollo de procesos de manufactura, asegurando eficiencia, mejora continua y cumplimiento de los requerimientos regulatorios aplicables a dispositivos médicos.Liderar el desarrollo e implementación de estrategias de ingeniería enfocadas en eficiencia, escalabilidad y cumplimiento regulatorio en procesos de...