Environmental And Sterilization Quality Engineer

Descripción y detalle de las actividadesResponsibilities: - Develop and Coordinate Environmental and Sterilization Plans to comply with applicable regulations. - Provide support on Environmental and Sterilization Validations, including but not limited to the development of Protocols and Reports. - File, update, and maintain Environmental and Sterilization records in accordance with applicable regulations and licenses. - Develop, update, and/or implement sampling plans applicable to environmental and/or sterilization processes. - Audit Environmental, Manufacturing, and Sterilization processes. - Coordinate and follow up on CAPAs, NCMRs, and/or Complaints related to Sterilization and Environmental, as well as the follow-up and risk management evaluation. - Customer communication on any item related to Sterilization and Environmental issues. - Provide support to QMS plans.Experiência y requisitos- Bachelor's degree on Microbiology, Biochemical Engineering, QFB, or similar - Experience in medical manufacturing environment conditions and controls - Knowledge Environmental/Sterilization process and applicable standards - Knowledge of ISO 13485:2016, CFR 21, Cofepris, and other applicable standards - Bilingual, English 80% - Teamwork focus, Proactive - Computer skills (Microsoft Office) - Internal Auditor ISO 13485:2016 Certified**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Titulo Profesional**Sexo** Indistinto**Disponibilidad p. viajar** No