Quality Systems Manager

ICU Medical Tijuana; Tijuana; Presencial; MXN 400,000 - 600,000; Jornada completa

Descripción de la vacante

Una empresa líder en dispositivos médicos en Tijuana busca un representante del Gerente de Calidad. Este rol implica gestionar la conformidad regulatoria, asegurar la efectividad del sistema de calidad y formar al personal en buenas prácticas. Se requiere una licenciatura en ingeniería y más de 7 años de experiencia en la industria de dispositivos médicos. Se ofrece un paquete de beneficios competitivo que incluye seguro de vida y servicios médicos en planta.

Servicios

Seguro de vida

Fondo de ahorro

Seguro de gastos médicos

Transporte

Plan de indexación

Guardería

Utilidades garantizadas

Caja de ahorro

Servicios médicos en planta

Comedor

Bonos anuales

Formación

• Más de 7 años de experiencia en la industria de dispositivos médicos.
• Certificaciones ASQ preferidas.
• Experiencia en FDA / cGMP / QSR, ISO 9001 / ISO13485 y Marcado CE.
• Experiencia en liderazgo de equipos multifuncionales.

Responsabilidades

• Gestionar y mejorar la conformidad regulatoria sustancial.
• Asegurar que el sistema de calidad sea efectivo.
• Realizar revisiones mensuales de QA/RA con el personal del sitio.
• Formar a todo el personal en el Sistema de Calidad y buenas prácticas de manufactura.

Conocimientos

Conocimientos sólidos de control estadístico de procesos (SPC)

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Inglés (hablar, entender, leer y escribir)

Habilidades de análisis de Pareto

Habilidad para crear y fomentar un ambiente de equipo

Habilidad para negociar e influir

Fuertes habilidades de toma de decisiones

Capacidad para manejar información confidencial

Educación

Licenciatura en Ingeniería

Descripción del empleo

Descripción y detalle de las actividades

Representative of the Quality Manager for the Tijuana Site before all Regulatory Agencies such as FDA, JPAL, CMDCAS, MDR, COFEPRIS and all those applicable to the Site.

Essential Duties and Responsibilities

• Manages, plans, maintains and improves substantial regulatory compliance with applicable regulations.
• Manages the regulatory risk of the product and processes of the Tijuana Site.
• Ensures that the Quality System is effective and initiates corrective / preventive actions as necessary.
• Conducts monthly QA / RA reviews with site staff.
• Conducts quality management reviews to evaluate the quality system and scale as necessary.
• This position is necessary to ensure compliance of Company operations with all applicable laws, regulations and standards, good business practices and documented company procedures (including knowledge of all government occupational health rules, regulations and statutes). and environmental issues related to the site).
• Participate and lead cross-functional teams to implement continuous improvement of the Quality System.
• Actively attend Level 3 meetings and staff meetings as necessary to provide guidance and status of quality system metrics.
• Manage and supervise processes related to the Quality System such as Document Control, Calibration, CAPA System, Complaint Analysis, Internal Audits.
• Train all staff in understanding the Quality System, as well as GMP Good Manufacturing Practices and Good Documentation Practices.
• Establish strategies to promote knowledge of regulatory requirements.

Other duties assigned by the supervisor.

Experiencia y requisitos

Knowledge and Skills

• Solid knowledge of statistical process control (SPC); capacity, verification and validation of the process; metrology; inspection techniques; reliability statistics, sampling plans and FMEA. Only candidates with that background will be considered.
• Intermediate skill level in Microsoft Word, Excel and PowerPoint
• Skills in speaking, understanding, reading and writing the English language.
• Ability to work with mathematical concepts such as probability and statistics.
• Ability to perform Pareto analysis to identify root causes of problems
• Ability to create and foster a team environment.
• Ability to negotiate and influence
• Strong decision-making skills are desired, but you must also know when to seek help.
• Proven track record of successful commitment to quality standards.
• Ability to plan and prioritize activities
• Ability to handle confidential information

Minimum Qualifications, Education and Experience

• Minimum Bachelor's Degree (B.S.) in Engineering and more than 7 years of experience in the medical device industry and in the position.
• ASQ certifications preferred.
• Experience in FDA / cGMP / QSR, ISO 9001 / ISO13485 and CE Marking.
• Experience in articulating the requirements and implementation of Good Manufacturing Practices (cGMP) to the Manufacturing of Medical Devices.
• Experience in leading multifunctional teams and projects to improve quality systems.
• Experience with medical devices.

Educational requirements may be obtained through an educational institution or obtained through equivalent work experience.

Beneficios

• Beneficios de acuerdo a la LFT
• Seguro de vida
• Fondo de ahorro
• Seguro de gastos médicos
• Transporte
• Plan de indexación
• Guardería
• Utilidades garantizadas
• Caja de ahorro
• Servicios medicos en planta
• Comedor
• Bonos anuales