Quality and Regulatory Affairs Lead
hace 4 semanas
Descripción y detalle de las actividades- Develop and coordinate regulatory plans with full implementation of new and modified products.- ** Surveillance** of the compliance of the Quality Management System.- Suggests and implements measures to improve QMS performance.- **Coordinate**regulatory research to support regulatory submissions and regulatory advice.- Coordinate and prepare regulatory information, including 510ks, technical Files and others (as applicable) to compliant with international regulation.- **Review** engineering changes (as applicable) to support regulatory compliance.- File, update, and maintain regulatory submissions in accordance with current US and foreign regulations for facility registrations, certifications, and licenses.- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.- **Manage**Document Control area and assign task and responsibilities including but not limited to resources and priorities.- **Manage**and coordinate internal, external and supplier audits to follow national and international regulation. Participate in the performance of the environmental management system in accordance with current roles and responsibilities.- Coordination of calibration activities.- Issue and monitoring Customer Complaints, CAPAs, NCMRs.- Review and issue Hazzard Substances certificates.- Audit our systems based on standards requirements.- Manages and supervises quality control and training reports for proper follow-up.- Set and track quality assurance goals.- Coordinate with internal / external quality assurance auditors to ensure legal compliance.- Work with internal teams to increase customer satisfaction by improving the quality of- the products.Experiência y requisitos**EDUCATION and/or EXPERIENCE**- Bachelor’s Degree in Engineering (industrial, chemical, mechanical, or related).- Ideal to have 3-5 years of experience in medical device manufacturing processes.- ISO 13485 certified internal auditor.- Knowledge QSR/JPAL/CE Mark requirements- Risk Management analysis.- Advance Computer skills (Minitab, Office, Word, Excel, Power Point, and/or Application Programs, Statistical Software, Databases. Etc.).- Ideal to have advanced training skills.- Knowledge of National and International Medical Manufacturing Quality Standards.- Certification Desirable (Green Belt, Certified Lead Auditor, Certified Quality Engineer, or any other related.)- Knowledge of ISO 14001 Environmental management System.- Leadership skills.**SUPERVISOR RESPONSIBILITIES**- Manages the payroll of assigned team (attendance and punctuality)- Manages discipline of assigned team (reporting to HR any faults to code of conduct or internal rules code)- Responsible for the training on job to perform and quality system mandatory requirements of- training for the assigned team.- Manages performance of current position and administrates performance reviews and career path for the assigned team.Beneficios- Beneficios de acuerdo a la LFT- Seguro de vida- Seguro de gastos médicos- Servicios medicos en planta- Comedor- seguro de vida- comedor**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Horario**- Tiempo completo**Estudios** Carrera con título profesional**Inglés**Hablado: Avanzado, Escrito: Intermedio**Disponibilidad p. viajar** No
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