This role is within a leading global medical device organization focused on advancing the treatment of vascular disease.
The Sterilisation Manager is responsible for ensuring all sterilization activities are compliant with relevant corporate and divisional policies, procedures, and regulatory requirements.
Key Responsibilities: Lead a team responsible for sterilization qualifications related to new product introductions and changes to existing products.
Oversee validation processes for radiation-sterilized products, including dose setting and routine quarterly audits.
Direct validations for ethylene oxide (EO)-sterilized products, including new product qualifications, annual revalidations, EO residual studies, and D-value studies.
Provide sterilization subject matter expertise to support Product Development and Operations teams.
Support Supplier Quality in auditing contract sterilization providers and third-party manufacturers.
Manage investigations of dose audit failures and EO biological indicator sterility positives.
Education