Compliance Engineer
Core
Ensuring manufacturing compliance, managing equipment assets, and driving continuous improvement for blood glucose test strip and sensor production.
Role type
Manufacturing Compliance Engineer
Builds
FreeStyle blood glucose test strips and FreeStyle Sensors
Domain
Medical Devices / Diabetes Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA investigation, OOS analysis, audit readiness, change control management, asset management, continuous improvement planning, KPI monitoring, 6S implementation
Preferred skills
Engineering or Manufacturing background, 4+ years in similar environment
Technologies
Asset Management Systems, Maintenance Systems
Responsibilities
Complete impact assessments and investigations for non-conformances and out-of-specifications, support cross-functional OOS investigation teams, ensure audit readiness for operations, update work instructions and operation procedures, manage equipment assets and maintenance systems, support engineering teams in maintaining facility and utility standards, develop continuous improvement plans for manufacturing processes, coordinate process and equipment projects, review and support approval of change control documents, ensure adherence to 6S standards
Seniority
Mid-level, hands-on IC
