Sterilization Engineer
hace 7 meses
Descripción y detalle de las actividades
Asegura que la calificación de proveedores, validaciones, revalidaciones, controles de proceso y liberación de producto terminado relacionados a los procesos de esterilización se lleven acabo y cumplan con los requerimientos establecidos en las regulaciones y normas aplicables.
Experiência y requisitos
Inglés avanzado Conocimientos avanzados en ingeniería de calidad: Manejo de producto no conforme, Control de procesos MFG/ Manejo de producto terminado/Análisis de datos y monitoreo Conocimientos avanzados en sistemas de calidad (ISO 13485-2016 MDSAP, FDA-QSR’s, EU MDR, CANADA): Manejo de CAPA/SCAR Auditorías Internas y Externas Control proveedores" Herramientas de investigación de causa raíz avanzadas (Metodología 8D’s, DMAIC, etc.) y solución de problemas Herramientas estadística avanzada (Indice de capacidad de procesos, Diseño de experimentos, ANOVA, análisis de probabilidad y distribución). Herramientas de mejora continua (Lean Manufacturing / Six Sigma). Conocimiento en procesos de esterilización (Gamma ISO 11137 / EO ISO 11135) Conocimiento en sistemas de validaciones (MVP / Mantenimiento estado validado) Uso avanzado de herramientas de análisis de riesgo Conocimiento en pruebas microbiológicas Conocimiento en controles, monitoreo y validación de áreas de ambiente controlado (ISO 14644 / NOM-241)
Organización
Mediméxico, S. de R.L. de C.V
Giro
Maquiladora (Export.)
Actividad principal
Somos empresa lider en la manufactura de productos médicos.
Número de empleados
3000
/**Área** Calidad
**Contrato** Permanente
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Carrera Profesional
**Sexo** Indistinto
-
Sterilization Engineer
hace 8 meses
Tijuana, México Corza Medical A tiempo completo**Vacancy Name** - Sterilization Engineer **Location of Work** - Tijuana, Mexico **Employment Type** - Full Time Employee **Our brand promise** We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.- **Remarkable service** A seamless,...
-
Sterilization Engineer
hace 7 días
Tijuana, México Flex A tiempo completoAt Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in...
-
Sterilization Engineer
hace 3 semanas
Tijuana, México Flex A tiempo completoThrough the collective strength of 170,000 team members across 30 countries and responsible, sustainable operations, Flex, a Fortune global 500 company, is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We welcome people of all backgrounds. A career with...
-
Sterilization Quality Engineer
hace 8 meses
Tijuana, México Flex A tiempo completoFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the...
-
Environmental and Sterilization Quality Engineer
hace 8 meses
Tijuana, México Carlisle Medical Technologies A tiempo completoDescripción y detalle de las actividades Responsibilities: - 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...
-
Environmental and Sterilization Quality Engineer
hace 7 meses
Tijuana, México Carlisle Companies A tiempo completoMinimum Requirements: - 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% -...
-
Sterilization Quality Engineer
hace 7 meses
Tijuana, México Flex A tiempo completoFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the...
-
Tijuana, Baja California, México Carlisle Medical Technologies A tiempo completoJob Overview:We are seeking a highly skilled Environmental and Sterilization Quality Engineer to join our Quality team at Carlisle Medical Technologies.About the Role:This is a permanent, full-time position with a standard business schedule from Monday to Friday with regular working hours.No travel is required for this role.Main Responsibilities:Develop and...
-
Quality Engineer
hace 2 semanas
Tijuana, México TACNA OUTSET A tiempo completoReview systems and processes to develop continued improvements through data analysis. - Support or execute change orders for process improvements and determines when process stability and capability studies should be performed on existing processes. - Analyzes and performs failure analysis (investigations) to non-conforming products. - Leads in the...
-
Sterility Assurance Engineer I
hace 3 meses
Tijuana, México Merit Medical A tiempo completoDescripción y detalle de las actividades Performs complex technical work pertaining to sterilization and microbiology such as validations and product adoptions under broad supervision and guidelines. ESSENTIAL FUNCTIONS PERFORMED 1. Writes sterilization validation protocols and final reports. 2. Coordinates sterilization validations, including annual...
-
Quality Engineer
hace 2 semanas
Tijuana, México Emprego MX A tiempo completo**Descripción y detalle de las actividades** **Experiência y requisitos** - Bachelor's degree in engineering or technical field or equivalent experience is required. - Minimum of 5 years of quality experience in a medical device or other regulated industry is required. Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO...
-
Quality Engineer
hace 5 días
Tijuana, México Outset Medical A tiempo completo**Company Overview** Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally...
-
Senior Quality Assurance Engineer
hace 3 días
Tijuana, Baja California, México Outset Medical A tiempo completo**About Outset Medical**We are a pioneering medical technology company dedicated to transforming the dialysis experience for patients and simplifying it for providers. Our innovative Tablo Hemodialysis System represents a significant technological advancement, cleared by the FDA for use from hospitals to homes.Tablo serves as a single enterprise solution...
-
Microbiologist-steriliz Engineer Ii
hace 7 meses
Tijuana, México Medtronic A tiempo completo**Careers that Change Lives **A Day in the Life Responsibilities may include the following and other duties may be assigned. - Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program. - Prepares, cleans, disinfects, and/or sterilizes...
-
Quality Engineer I
hace 5 días
Tijuana, México Medtronic A tiempo completo**Careers that Change Lives** **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. - Collaborates with engineering and manufacturing functions to ensure...
-
Quality Assurance Specialist for Medical Devices
hace 6 días
Tijuana, Baja California, México Stryker A tiempo completoAbout StrykerStryker is a leading medical technology company dedicated to improving lives with innovative products and solutions. Our passion for research and development has earned us a reputation as a trusted partner in the healthcare industry.Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team in New Products...