Teams at CICONIX, LLC

Supports regulatory risk, quality management, knowledge management, and clinical research compliance for FDA-regulated medical products. Responsibilities include developing quality systems and SOPs, managing training compliance, preparing submissions and audit plans, conducting audits and inspections, investigating nonconformances, implementing CAPAs, performing ISO 14971 risk management, reviewing documentation and facilities, and providing regulatory and quality training to internal staff, clinical sites, CROs, CMOs, and other supported entities.

Manages inbound and outbound shipments, receiving, storage, distribution, property accountability, medical supplies, and equipment turn-ins for a military medical research organization. Maintains logistics records and databases, coordinates vendors and deliveries, processes procurement requests, supports shipping accounts, performs material handling, and prepares reports and administrative documents. Requires adherence to storage, safety, PPE, packaging, and government logistics procedures.

Supports the Defense Health Agency Medical Simulation and Training PMO through acquisition documentation, market research, contract and solicitation reviews, requirements analysis, funding compliance, program scheduling, IPT coordination, meeting support, action tracking, and SharePoint configuration management. The role also assists with proposal evaluations, acquisition planning, scope and cost estimates, document quality control, and maintaining program records in accordance with DHA, DoD, and federal acquisition policies.