Responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Work with suppliers as needed to ensure their performance is acceptable per site requirements. Have the ability to work with Technical Services, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner.
This position requires a thorough understanding of ISO/QSRs and the ability to understand various manufacturing processes. Knowledge of regulations and standards affecting IVDs and Biologics. Knowledge of regulations and standards affecting in vitro diagnostic's device manufacturing. Bachelor degree in engineering, or science related field or 5+ years of related experience. ISO lead auditor certification or equivalent is desirable but previous experience in internal/external auditing may be substituted.
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responsibilities effectively.