Global Gamma Sterilization Quality Lead
Sanisure Llc
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Job summary
SaniSure in Camarillo, CA is seeking a Senior Global Quality Engineer – Sterilization to oversee gamma irradiation sterilization processes across a global network. You will ensure compliance with ISO 11137, ISO 13485, ISO 14937, and FDA/EU requirements, lead dose audits, and support new product introductions.
The role includes evaluating bioburden data, maintaining audit programs, managing contract sterilizers, leading risk assessments, and mentoring junior engineers.
Job description
SaniSure in Camarillo, CA is seeking a Senior Global Quality Engineer – Sterilization to oversee gamma irradiation sterilization processes across a global network. You will ensure compliance with ISO 11137, ISO 13485, ISO 14937, and FDA/EU requirements, lead dose audits, and support new product introductions.
The role includes evaluating bioburden data, maintaining audit programs, managing contract sterilizers, leading risk assessments, and mentoring junior engineers.
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