GENERAL SUMMARY The Sr. CAPA Engineer oversees the Corrective Action & Preventive Action (CAPA) systems, Non-Conformance (NC) systems, and Internal Audit programs. The CAPA engineer ensures that all requirements as specified in 21 CFR 820.100, 820.90, 820.22 and ISO 13485 (Sections 8.4, 8.5, 8.2.2) are properly administered. Additionally, this position is responsible for driving continuous improvement activities in these systems. The CAPA Engineer ensures that procedures are clearly defined and implemented to fulfill regulatory and business requirements for all products/product lines manufactured by InfuTronix. ESSENTIAL JOB FUNCTIONS* Administrative duties include but are not lim
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