Global Gamma Sterilization Quality Lead

Sanisure Llc; Camarillo (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

SaniSure in Camarillo, CA is seeking a Senior Global Quality Engineer - Sterilization to oversee gamma irradiation sterilization processes across a global network and drive process improvements. You will ensure compliance with ISO 11137, ISO 13485, ISO 14937, and FDA/EU requirements, lead dose audits, evaluate bioburden data, maintain audit programs, and mentor junior engineers.

This role interfaces with contract sterilizers and suppliers to ensure safe, compliant sterilization across the

Responsibilities

• Oversee gamma irradiation sterilization processes across a global network.
• Ensure compliance with ISO 11137, ISO 13485, ISO 14937, and FDA/EU requirements.
• Lead dose audits and evaluate bioburden data.
• Maintain audit programs and manage contract sterilizers.
• Mentor junior engineers and support new product introductions.

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.