Quality Systems Manager

Descripción y detalle de las actividadesRepresentative 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**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.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 governmental occupational health and safety standards, regulations and statutes). environmental conditions related to the site).Other duties assigned by the supervisor.Experiência y requisitosKnowledge and Skills- 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 informationMinimum 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- seguro de vida- bonos anuales- caja de ahorro**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Horario**- Tiempo completo**Estudios** Maestría**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p. viajar** Si