Sr Quality Engineer - Design

ICU Medical Tijuana; Tijuana; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

Una empresa en el sector de dispositivos médicos en Tijuana busca un Ingeniero de Calidad Sénior. El candidato será responsable del cumplimiento de los estándares de calidad y regulaciones en el desarrollo y manufactura de productos. Se requiere un título en ingeniería y al menos 7 años de experiencia en la industria. Ofrecemos beneficios competitivos y un entorno de trabajo dinámico.

Servicios

Guardería

Utilidades garantizadas

Seguro de vida

Comedor

Fondo de ahorro

Transporte

Seguro de gastos médicos

Servicios médicos en planta

Formación

• 7+ años de experiencia en la industria de dispositivos médicos.
• ASQ CQE o CSQE requerido o habilidad para obtener en un año.
• Experiencia en gestión de riesgos relacionados con el QMS.

Responsabilidades

• Utilizar herramientas y procesos de calidad para asegurar la calidad del producto.
• Asegurar la conformidad con regulaciones de la FDA.
• Trabajar con equipos multifuncionales para coordinar cambios de producto.

Conocimientos

Conocimiento de normas de dispositivos médicos

Habilidades de comunicación en español e inglés

Uso de herramientas de calidad

Educación

Título en ingeniería

Descripción del empleo

Descripción y detalle de las actividades

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 support for product realization / manufacturing teams. Reporting to the Quality Manager, this individual will be the Quality Core Team Member for ensuring products are developed / manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.

Essential Duties & Responsibilities

• Effectively utilize quality tools and processes such as product and process controls, risk analysis / management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
• Assures conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
• Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
• Work with cross-functional teams to coordinate product changes.
• Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
• Provide corporate quality support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary.
• Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
• Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks.

Experiencia y requisitos

• Bachelor’s degree in engineering from an accredited college or university is required.
• Minimum of 7+ years similar role in Medical Device Industry
• ASQ CQE or CSQE required or the ability to obtain within one year.
• Strong knowledge of medical device standards, including but not limited to : ISO 13485, ISO 14971, FDA, MDR and other key medical device regulations.
• Experience linking risk management to all elements of the QMS (Design Controls, CAPA, Complaints, Doc Control, etc)
• Excellent Bilingual Spanish / English verbal and written communication skills

Beneficios

• Guardería
• Utilidades garantizadas
• seguro de vida
• caja de ahorro
• comedor
• fondo de ahorro
• transporte
• seguro de gastos médicos
• plan de indexación
• servicios médicos en planta