Deciphex Benefits Overview

Manages quality assurance and regulatory affairs for North American clinical laboratory operations and digital pathology products. Responsibilities include audits, CAPAs, deviations, incident investigations, validation, inspection readiness, regulatory submissions, post-market surveillance, regulatory gap assessments, privacy compliance, training, and quality metrics. The role requires expertise in US laboratory regulations, FDA requirements, clinical services, medical devices, and quality management systems, with approximately 10% international travel.

Own electronic document control, training administration, eQMS workflows, controlled document reviews, physical records, supplier certification, KPI reporting, and audit support. Administer Greenlight Guru, train colleagues, manage onboarding and offboarding training, and provide backup support for CAPA, deviations, and change management across international sites.

Senior backend engineer responsible for designing, developing, testing and deploying on-premise and cloud microservices for an AI-driven digital pathology product. Work with cross-functional agile teams, use containerization and cloud tech, support monitoring and troubleshooting, drive development best practices, and complete required regulated-environment compliance training.