Sterilization Quality Engineer
hace 3 semanas
Flex 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 limits of innovation to make great products that create value and improve people's lives.Job SummaryTo support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Sterilization Quality Engineer located in Tijuana.Reporting to the Quality Manager the Sterilization Quality Engineer’s role involves:What a typical day looks like:- Develops and initiates procedures for sterilization release and validation.- Coordination and evaluation of non-conformant product disposition related with sterilization excursions.- Support workers engaged in monitor sterilization metrics.- Provide training to workers related with sterilization process.- Review and analyze bioburden and dose audits data.- Review and analyze endotoxin testing results.- Coordinate and conduct sterilization validation process for ethylene oxide and radiation methods.- Initiates corrective action requests as needed and tracks to satisfactory completion.- Determine appropriate validation, process controls and monitoring (e.g. dose audits, parametric release, process challenge device (PCD), residuals, etc.) are properly implemented to ensure Sterility Assurance Level (SAL). Ensure the process is documented in accordance with industry standards: ISO 11135, ISO 11137.The experience we’re looking to add to our team:- Advanced English- Typically requires a bachelor’s degree,- Able to use Office system: Word, Excel, Power point, etc.- Communicate and escalate situations on time.- Understand EO and radiation concepts.- Material classification: Assess and classify product and process defects and nonconformities.- Knowledge in Quality System conceptsWhat you’ll receive for the great work you provide:- Pantry vouchers- Saving Fund- Christmas bonus- Holiday bonus- Medical Insurance- Life InsuranceEM57Job CategoryQuality**Required Skills**:Optional Skills:
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Sr. Sterilization Engineer
hace 2 semanas
Tijuana, México Mammotome A tiempo completoSterilization Engineers are responsible for providing technical expertise and business leadership to engineering, operations, regulatory teams in sterilization and microbiological areas. The basic function of the Sterilization Engineer at the manufacturing site is to plan, coordinate and direct the sterilizatio program to ensure continuous accomplishment of...
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Sr. Sterilization Engineer
hace 2 días
Tijuana, México Mammotome A tiempo completoSterilization Engineers are responsible for providing technical expertise and business leadership to engineering, operations, regulatory teams in sterilization and microbiological areas. The basic function of the Sterilization Engineer at the manufacturing site is to plan, coordinate and direct the sterilizatio program to ensure continuous accomplishment of...
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Sr. Sterilization Engineer
hace 2 días
Tijuana, México Mammotome A tiempo completoSterilization Engineers are responsible for providing technical expertise and business leadership to engineering, operations, regulatory teams in sterilization and microbiological areas. The basic function of the Sterilization Engineer at the manufacturing site is to plan, coordinate and direct the sterilizatio program to ensure continuous accomplishment of...
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Sr. Sterilization Engineer
hace 2 días
Tijuana, México Mammotome A tiempo completoSterilization Engineers are responsible for providing technical expertise and business leadership to engineering, operations, regulatory teams in sterilization and microbiological areas. The basic function of the Sterilization Engineer at the manufacturing site is to plan, coordinate and direct the sterilizatio program to ensure continuous accomplishment of...
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Sr Sterilization Validations Engineer
hace 3 semanas
Tijuana, México Centerpiece S. De R.L De C. V. A tiempo completoThe Sr Sterilization Validations engineer will:- The Sr Sterilization Validations engineer eventually will work with a significant degree of independence and self-direction to ensure the developing, implementing, and executing validation related programs in compliance withCENTERPIECE's QMS and compliant to 21 CFR Section 820, EN ISO *****, ISO *****,...
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Sr Sterilization Validations Engineer
hace 3 semanas
Tijuana, México Centerpiece S. de R.L de C. V. A tiempo completoThe Sr Sterilization Validations engineer will:- The Sr Sterilization Validations engineer eventually will work with a significant degree of independence and self-direction to ensure the developing, implementing, and executing validation related programs in compliance withCENTERPIECE’s QMS and compliant to 21 CFR Section 820, EN ISO 13485, ISO 11135,...
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Sterilization Quality Engineer
hace 1 semana
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...
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Environmental and Sterilization Quality Engineer
hace 3 semanas
Tijuana, México Carlisle Interconnect Technologies A tiempo completoResponsibilities:- 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...
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Environmental and Sterilization Quality Engineer
hace 3 semanas
Tijuana, México Carlisle Medical Technologies A tiempo completoDescripción 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...
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Environmental and Sterilization Quality Engineer
hace 2 semanas
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% -...
