Description
Key Features -1. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
2. Conduct sterilization qualification for new products and/or changes to existing products.
3. Performs sterilization validation for radiation sterilized products including dose setting and quarterly dose audits.
4. Performs sterilization validation for ethylene oxide sterilized products including new product qualification, annual revalidations, residual EO studies, and D-value studies.
5. Provides product development teams sterilization Subject Matter Expert support
6. Assist in Supplier Quality audits of contract sterilization facilities and third party manufacturers.
7. Conducts dose audit failure investigations.
8. Conducts Ethylene Oxide Biological indicator sterility positive investigation.
Summary -
-Understands business environment and relates extensive knowledge of internal and external technological activities to trends.
-Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.
-Participates in the development of other technical contributors by facilitating training and providing feedback and guidance.
-May lead a project team.
-Provides technical leadership to business units.
-Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
-Exercises judgment independently.
-Plans and organizes project assignments of substantial variety and complexity.
-Initiates or maintains schedule for projects and project milestones.
-Establishes priorities of individual or project assignments.
-Selects methods and techniques to lead a project to completion.
-Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives
Skills and Experience -
Bachelor's degree plus 9+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience. Requires 5 to 10 years direct experience with Radiation and/or Ethylene Oxide sterilization. Comprehensive knowledge of a Radiation and or Ethylene Oxide sterilization. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment.
To find out more about Real please visit www.realstaffing.com