This role is within a leading global medical device organisation focused on advancing the treatment of vascular disease. The is responsible for ensuring all sterilisation activities are compliant with relevant corporate and divisional policies, procedures, and regulatory requirements.
Key Responsibilities:
1. Lead a team responsible for sterilisation qualifications related to new product introductions and changes to existing products.
2. Oversee validation processes for radiation-sterilised products, including dose setting and routine quarterly audits.
3. Direct validations for ethylene oxide (EO)-sterilised products, including new product qualifications, annual revalidations, EO residual studies, and D-value studies.
4. Provide sterilisation subject matter expertise to support Product Development and Operations teams.
5. Support Supplier Quality in auditing contract sterilisation providers and third-party manufacturers.
6. Manage investigations of dose audit failures and EO biological indicator sterility positives.
Education & Experience:
7. Bachelor's degree in a relevant discipline with a minimum of 9 years' related experience, or an equivalent combination of education and experience. An advanced degree is preferred.
8. Strong expertise in at least one sterilisation modality, such as Radiation or Ethylene Oxide.
9. Proven experience leading technical teams in sterilisation validation, troubleshooting, and compliance within a quality-regulated environment.
10. Demonstrated ability to solve complex problems requiring deep analysis and cross-functional collaboration.
11. In-depth knowledge of industry practices, regulations, and potential technical alternatives and their business impact.