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Sterilization Engineer
hace 2 semanas
Descripción y detalle de las actividades
Executes and assists in various routine sterilization and validation related activities for the Mxl Medline Distribution Center. Ensure product processing, regulatory requirements, and equipment requirements are met in accordance with specifications including calibrations, internal, customer and regulatory audits, validations, record keeping and reporting.
- Review sterilization records and all related documentation for completeness, accuracy, and to ensure they meet validated parameters prior to releasing product for distribution.
- Verification and transmittal of various biological and product samples for customers’ routine sterilization and validation loads.
- Assist in validation product load set up including placement of samples and sensors within product cases and distributed throughout a load. Configure samples and product cases onto pallets according to validation study instructions and retrieve samples at designated times after processing for transmittal to laboratory.
- Configure, set-up, and download sensors used for various customer validation and equipment qualification studies. Review and ensure sensors meet calibration specifications prior to and after studies as defined in Medline procedures or customer protocols.
- Interact with individuals from different disciplines (Production, Maintenance, and Customers) to plan, execute and complete EO validation activities according to time sensitive schedules.
- Maintain inventory and review usage logs for customer supplied biological indicators used for routine sterilization process monitoring and communicate with customers on needs
Experiência y requisitos
Bachelor Degree with a scientific or engineering background 3+ Years working in FDA/ISO 13485 regulated environment (Desirable) 1+ Years working in Medical Device manufacturing (Desirable) US VISA required English 80% Software: Microsoft Office SAP, AS400 (Desirable) Skills Proactive Able to manage multiple projects
Organización
Medline
Giro
Manufacturera
Actividad principal
Global manufacturer and distributor of medical products with patient-centered solutions.
Número de empleados
2500
**Área** Calidad
**Contrato** Permanente
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario** Lunes a viernes de 3:00 pm a 11:00 pm
**Estudios** Carrera Profesional
**Sexo** Indistinto
