Sterilization Quality Engineer

hace 1 semana


Tijuana, Baja California, México 890 AVAILMED, S.A. DE C.V. A tiempo completo

Job Summary

To 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 identification, status, and traceability: Define and distinguish between these concepts, and describe methods for applying them in various situations. Material segregation: Describe material segregation and its importance and evaluate appropriate methods for applying it in various situations. Material classification: Assess and classify product and process defects and nonconformities. Knowledge in Quality System concepts

What you'll receive for the great work you provide:

Pantry vouchers Saving Fund Christmas bonus Holiday bonus Medical Insurance Life Insurance

EM57

Job Category

Quality

Required Skills:

Optional Skills:

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).



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