Sterility Assurance Specialist (Medical Devices)

TL;DR

Sterility Assurance Specialist (Medical Devices): Planning and executing sterilization validations and reprocessing protocols for medical instruments with an accent on gamma, beta, and ETO sterilization processes. Focus on ensuring product cleanliness, managing clean room monitoring, and maintaining compliance within the Quality Assurance team.

Location: Must be based in San Daniele del Friuli, Italy

Company

hirify.global is an innovation-driven medical technology company dedicated to developing clinically differentiated solutions that improve patient outcomes and transform healthcare workflows.

What you will do

• Plan and perform sterilization validations and revalidations for gamma, beta irradiation, and ETO processes.
• Validate reprocessing procedures for instruments, including cleaning, disinfection, and sterilization.
• Monitor products, clean rooms, and water systems to demonstrate cleanliness standards.
• Evaluate new products and design changes for their impact on sterility and reprocessing requirements.
• Conduct OOS investigations and review test results related to product cleanliness.
• Participate in audits as a Subject Matter Expert and provide training on hygiene and sterility.

Requirements

• Technical Bachelor or Master Degree in life sciences or medical technology, or completed apprenticeship with 5 years of professional experience in medical devices or microbiology.
• At least 1 year of experience in quality assurance.
• Ability to work onsite in San Daniele del Friuli, Italy.
• Strong understanding of sterilization validation processes and regulatory standards.

Culture & Benefits

• Opportunity to work in a growing global medical technology company.
• Commitment to continuous improvement and innovation.
• Equal opportunity employer with a focus on merit-based career development.
• Collaborative environment within a global Quality Assurance team.