QA Engineer Digitial Systems
Core
Ensuring quality of site processes and digital manufacturing to Dexcom standards, supporting the product life cycle.
Role type
QA Engineer (Digital Systems & Manufacturing)
Builds
Digital manufacturing systems, MES, and quality management systems for medical devices.
Domain
Medical device manufacturing / Digital Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
compliance and validation of manufacturing and digital systems, risk-based validation principles, CAPA and Non-Conformance management, problem-solving tools, gap assessments for regulations/QMS, audit preparation and management
Preferred skills
experience working in digital systems, continuous improvement initiatives
Technologies
MES, Microsoft Office, database applications (Excel, MiniTab)
Responsibilities
Develop and use standardized validation templates and practices for digital manufacturing systems; apply risk-based validation principles to system implementation and changes; manage OOS events, CAPAs, NCMRs, and Change Orders; support integration of new regulations or QMS standards via gap assessments; support external inspections by regulatory bodies and notified parties
Seniority
Mid-level, hands-on IC
