Quality Systems Engineer
Core
Develop and optimize compliance processes for manufacturing, data collection, testing, and audit automation to ensure FDA and ISO standards.
Role type
Quality Systems Engineer
Builds
Efficient compliance systems and real-time performance dashboards
Domain
Medical Devices / Biomedical Engineering
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Process development, Compliance engineering, Analytical metrics creation, Deviation management, CAPA management, Document control, Change control, Training management, ISO 13485 knowledge, 21 CFR 820 knowledge
Preferred skills
Biomedical or Electrical Engineering background, Operational Excellence, Six Sigma principles, Basic coding and querying
Responsibilities
Gather requirements and design compliant processes, Develop quantifiable metrics displayed on dashboards, Drive process improvements for systemic compliance, Assist with deviation and audit findings tracking and closure, Own subsets of Quality Systems per ISO 13485 and 21 CFR 820
Seniority
Mid-level, hands-on IC
