Job responsibilities
* ensure compliance and maintenance of the quality management system (qms).
* support internal and external quality system audits, ensuring compliance.
* lead investigations, manage non-conformances (nc), and perform capa review and approval tasks.
* train new employees on ag’s procedures regarding quality management systems.
* plan and execute internal audits based on the processes of the organization.
* coordinate and provide applicable compliance training.
* interpret and apply regulations such as fda, iso, mdsap, eu mdr, and ag policies.
support trend analysis on key performance indicators and organize management reviews.
minimum qualifications
* bs in a science, engineering, or related discipline.
* 0 - 2 years of similar experience in a highly regulated industry.
* experience with the following regulations/standards preferred: 21 cfr part 820, mdsap, iso standards (e.g., iso 13485:2016, iso 14971:2019).
* knowledge of manufacturing processes, statistical techniques, environmental controls, and basic regulatory requirements for medical devices is preferred.
* knowledge of quality management system processes (nc/capa, complaints handling, management review, etc.) is preferred.
* bilingual (english & spanish).
* utilize proper software to maintain project records, including ms office, sharepoint, visio, and/or power bi.
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