Our Client's broad line of vascular devices–which includes vessel closure, endovascular and coronary technologies–are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
Purpose:
Sterilisation Manager is responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Key Responsibilities:
* Leads team that conduct sterilization qualification for new products and/or changes to existing products.
* Leads team that performs sterilization validation for radiation sterilized products including dose setting and quarterly dose audits.
* Leads team that performs sterilization validation for ethylene oxide sterilized products including new product qualification, annual revalidations, residual EO studies, and D-value studies.
* Leads team that provides product development and Operations teams sterilization Subject Matter Expert support
* Leads team that assist in Supplier Quality audits of contract sterilization facilities and third party manufacturers.
* Leads team that conducts dose audit failure investigations.
* Leads team that conducts Ethylene Oxide Biological indicator sterility positive investigation.
Education
Bachelor's degree plus 9+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
Experience
* Substantial knowledge of a Radiation and or Ethylene Oxide or other sterilization modality.
* Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an SME in work group and across functions.
* Ability to lead a technical team in the execution of sterilization validation/revalidation, new product qualification, troubleshooting sterilization issue. Will lead team performing this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
* Works on problems where analysis of situations or data requires an in-depth evaluation of various factors.
* Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.
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