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
- Ventajas 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 competente
**Inglés**Hablado: Avanzado, Escrito: Intermedio
**Disponibilidad p. viajar** No

📌 Quality and Regulatory Affairs Lead (Tijuana)
🏢 Amphenol CMT - Critical Medical Technologies
📍 Tijuana