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Sterilization Quality Engineer
hace 4 meses
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.
- 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
- Pantry vouchers
- Saving Fund
- Christmas bonus
- Holiday bonus
- Medical Insurance
- Life Insurance
- Site
