Senior Global Quality Engineer – Gamma Sterilization

Sanisure; Camarillo (CA); Hybrid; USD 120,000 - 130,000; Full time

Job summary

SaniSure, a high-growth medical device/pharma supplier, seeks a Senior Global Quality Engineer – Sterilization to lead gamma irradiation sterilization across a global manufacturing and supplier network. You will drive validation, dose audits, change control, and regulatory alignment with ISO 11137, ISO 13485, and FDA/EU standards.

Qualifications include a Bachelor's in Engineering/related field, 5–10 years in sterilization, and hands-on gamma sterilization expertise; travel 10–15% is expected.

Qualifications

• Bachelor's degree in Engineering, Microbiology, Biomedical Sciences, or related field.
• 5–10 years of experience in quality/sterilization engineering in medical devices/pharma.
• Hands-on gamma irradiation sterilization: dose mapping, dose audits, establishment methods.
• Strong knowledge of ISO 11137-1/-2/-3, ISO 11737-1/-2, ISO 14937, ISO 13485, FDA 21 CFR 820 and EU MDR.
• Experience with contract sterilizer qualification and management.
• Experience supporting customer/notified body audits and inspections.
• Travel up to 10–15% for site visits/audits.

Responsibilities

• Lead gamma sterilization validations (IQ/OQ/PQ) including dose mapping and product family bracketing.
• Serve as the technical authority for gamma sterilization process design, transfer, and revalidation.
• Own sterilization dose audit programs, with trend analysis and CAPA for non-conformances.
• Review bioburden data, product family groupings, and material compatibility to support SAL.
• Partner with cross-functional teams on new product development and transfers.

Skills

Gamma sterilization

ISO 11137 / ISO 13485

Regulatory compliance (FDA/EU)

Vendor qualification

Education

Bachelor's degree in Engineering / Microbiology / Biomedical Sciences

CQE or equivalent certification (preferred)

Job description

SaniSure, a high-growth medical device/pharma supplier, seeks a Senior Global Quality Engineer – Sterilization to lead gamma irradiation sterilization across a global manufacturing and supplier network. You will drive validation, dose audits, change control, and regulatory alignment with ISO 11137, ISO 13485, and FDA/EU standards.

Qualifications include a Bachelor's in Engineering/related field, 5–10 years in sterilization, and hands-on gamma sterilization expertise; travel 10–15% is expected.