Quality Sterilization Engineer - Contract
Quality Sterilization Engineer - Contract
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
What youll get to do:
- Oversee sterilization and reprocessing projects validations and monitoring in alignment with Quality System requirements.
- Maintain corporate sterilization practices per international standards (e.g. ISO 11135 ISO 11137 ISO 17665) and regulatory requirements.
- Coordinate validation and testing activities serving as the primary contact with laboratories and sterilization partners.
- Conduct and document assessments and validations for product and process changes affecting sterilization.
- Maintain comprehensive records of internal and vendor compliance including validation reports product assessments monitoring nonconformances and CAPAs.
- Assist manufacturing in defining infrastructure requirements to ensure effective contamination control.
What will make you successful:
- Knowledgeable of FDA and ISO guidelines for the sterilization assessment of medical devices required.
- Working knowledge of terminal sterilization methods (ISO 11135 ISO 11137 etc) required.
- Bachelors Degree
- 2-5 years of experience in engineering quality or manufacturing
Employment Type
Contract
