Sterility Assurance Specialist – QA (Microbiology)

About the role

Enovis is seeking a Sterility Assurance Specialist to join its Quality Assurance team at the San Daniele del Friuli site in Italy. The role focuses on planning, executing and evaluating sterilization and re‑processing validations to ensure product safety and regulatory compliance.

Key responsibilities

• Plan, perform and assess validation and re‑validation studies for gamma, beta and ethylene oxide (ETO) sterilization, including dose establishment, dose mapping, MPQ and PPQ.
• Conduct validation of instrument re‑processing (cleaning, disinfection and sterilization) and document outcomes.
• Design and execute monitoring tests on final products, clean‑rooms and water systems to demonstrate cleanliness.
• Evaluate new products and process changes for sterility impact, assigning them to appropriate sterilization families or performing required validations.
• Review test results, investigate out‑of‑specification findings and support corrective actions.
• Provide training on hygiene, product cleanliness and sterility concepts.
• Participate as a subject‑matter expert in internal and external audits.

Required profile

• Technical Bachelor’s or Master’s degree in life sciences, medical technology or a related field.
• Experience in sterilization validation, clean‑room monitoring or related quality‑assurance activities.
• Strong analytical mindset and ability to document decisions and investigations.

Required skills

• Gamma irradiation validation
• Beta irradiation validation
• ETO sterilization validation
• Process validation (MPQ, PPQ)
• Clean‑room and water monitoring
• Out‑of‑specification investigation