Descripción y detalle de las actividades
- Manager is responsible for the efficient flow of materials, safe use of ETO, and proper risk management.
- Lead, coordinate, and oversee operations related to ethylene oxide (ETO) sterilization processes, ensuring compliance with national and international regulatory standards (such as NOM, ISO 11135 and 13485, FDA 21CFR820, and OSHA), current Good Manufacturing Practices (cGMP), health and safety regulations, and customer commitments.
- **Supervises the calibration, warehouse and Operations teams and enforces strict adherence to validated parameter.
- Manager leads the operations team by promoting a culture of discipline, safety, and continuous improvement, while ensuring ongoing training and development of team members.
- Authorize the weekly operations schedule according to priorities and prior commitments made with clients.
- Elaborates, maintains and manages the department budget.
- Oversees inventory control of raw materials, processed and unprocessed product; develops weekly material flow plans.
- Ensure that the work in the area is conducted according to standard operating procedures and quality guidelines, good manufacturing practices, and health and safety regulations.
- Supervise the proper functioning of process control equipment.
- Supervise the biological indicator inventory report for clients for routine processes.
- Initiate and follow up on corrective actions derived from process nonconformities.
- Supervise the ETO gas inventory report.




- Coordinate and approve overtime for Operations staff.
- Creates and presents KPI on the weekly, monthly and quarterly meetings with company stakeholders.
- Work closely with Commercial Team providing updates on the production status of materials at the plant and their scheduling.
- Interfaces with all customers as the customer service representative and provides status of the customer loads on agreed upon timeframes
Experiência y requisitos
- Extensive knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485 and ISO 11135.
- Ability to manage multiple projects successfully.
- Strong professional presence with the ability to interact with associates at all levels, including executive management and customers.
- Highly motivated, self-starter with initiative to improve processes.
- Excellent interpersonal skills and a collaborative management style.
- Ability to foster and actively contribute to a positive team environment.
- Demonstrated commitment to high ethical standards and workplace diversity.
- Strong safety commitment.
Beneficios
- Beneficios de acuerdo a la LFT
**Número de vacantes** 1
**Área** Química
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Jornada completa
- Flexible
**Salario mensual neto** $80,000 - $90,000 MXN
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** Si

📌 Operations Manager (Tijuana)
🏢 Importante empresa
📍 Tijuana