Quality Assurance Engineer
Core
Support the Quality Assurance organization with quality improvement, manufacturing troubleshooting, and new product introduction support for medical devices.
Role type
Quality Assurance Engineer (Medical Devices)
Builds
Medical devices (AEDs, ventilators, trauma kits) and related software solutions
Domain
Medical device manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
problem solving, statistical analysis, ISO 13485, ISO 14971, FDA QSR, process capability, process control, measurement system capability
Preferred skills
ASQ Certified Quality Engineer
Technologies
ISO 13485, ISO 14971, FDA QSR
Responsibilities
Lead product complaint investigations, develop and implement quality improvement programs, support manufacturing process validations, provide technical guidance to QA/QC personnel, collect and analyze quality data, participate in Material Review Board activities, engage in internal and external audits, participate in CAPA program
Seniority
Mid-level, hands-on IC