Sterilization Sr Engineer
hace 1 semana
**Descripción y detalle de las actividades**
- Provide quality assurance and technical sterilization support to the terminal sterilization of medical devices and other healthcare products. The position will support the Medline Product Divisions and external customers in order to maintain compliance with regulations and industry standards including 21 CFR Part 820, ISO11135, and ISO13485.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.Monitor trending and data relative to quality system and make recommendations for improvement as well as establish implementation plans. Prepare reports for monthly, quarterly, and semi-annual trending and host monthly Quality Review Board meetings with Management.Perform or facilitate the review and maintenance of equipment calibration and qualification records per established procedures. Maintain equipment calibration and qualification schedules for the facility to ensure activities are completed within specified time frames.Review preventive maintenance records to ensure they are completed as scheduled. Review unscheduled maintenance and initiate/review equipment change control documentation to ensure process equipment remains in its validated state.Facilitate the maintenance of local training documentation for plant employees. Develop training materials and train employees in response to procedural change, policy changes and improvement activities. Create and update NPS
**Experiência y requisitos**
- Bachelor's degree with a scientific or engineering background, other US VISA6+ Years working in Medical Device manufacturing
- required6+ Years working in FDA/ISO 13485 regulated environment-requiredEnglish 90%Office Windows: Word, Excel, Power Point,SAP, AS400Design Control Process/IQ/OQ/PQ-requiredKnowledge in ISO standar 11135-Desirable
**Organización**
- Medline**Giro**
- Manufacturera**Actividad principal**
- Global manufacturer and distributor of medical products with patient-centered solutions.**Número de empleados**
- 2500**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Carrera Profesional**Sexo** Indistinto
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