Serve as the primary Quality Assurance point of contact for Materials Management. Review and approval of incoming and in-process raw materials and components for use in GMP manufacturing and testing.  Review and approval of sanitized kits.Manage change controls, CAPAs, deviations, and quality events relating to Materials Management.

Initiated and supported both internal and external quality audits, encompassing front-room and back-room processes, to demonstrate compliance to regulatory standards and drive continuous improvement initiatives. Conducted reviews and maintained oversight of equipment records, encompassing calibrations, repairs, validations, including in-depth assessments of their implications on the Quality Management System (QMS). Reviewing process and equipment logbooks to ensure accuracy and completeness. Acted as the primary point of contact for the efficient organization, filing, and retrieval of critical quality documentation, ensuring accessibility and compliance within the QMS.

Authored and executed validation protocols, collaborating with cross-functional teams, providing quality reviews and guidance to ensure compliance with regulatory standards. Responsible for the review of Device History Records (DHRs) from production, verifying the accuracy and completeness of documentation before product release, ensuring adherence to quality standards and regulatory requirements. Played a pivotal role in documenting and addressing process deviations from established procedures, ensuring timely and thorough investigations and corrective measures. Addressed audit findings from internal and external audits, collaborating cross-functionally to close gaps, improve processes, and sustain compliance with regulatory requirements.