Jobs at SoftWave TRT

Leads technical operations across service, engineering support, facilities, and equipment infrastructure. Manages approximately 10 employees while improving throughput, cost, quality, service turnaround, reliability, equipment uptime, and operational scalability. Establishes KPIs, dashboards, SOPs, planning models, maintenance and calibration programs, and service workflows. Oversees applicator and device servicing, engineering support, facilities readiness, and regulated operational processes in an early-stage medical device environment.

Lead and maintain the medical device Quality Management System (QMS) to ensure ISO 13485 and FDA QMSR compliance. Own CAPA, supplier quality, document/change control, audit readiness, and regulatory support. Drive corrective actions, supplier oversight, audits, training, and cross-functional collaboration to maintain compliance and enable company growth.