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 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 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:
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