QA Engineer
Core
Oversee product quality from assembly to packaging, ensuring compliance with quality systems and regulations while driving quality improvement projects.
Role type
Quality Engineer (Manufacturing)
Builds
Quality assurance processes and compliance for medical devices
Domain
Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS), CFR Part 820, ISO 13485, CAPA, deviation management, data analysis, test method validation, equipment qualification, audit support, team supervision
Preferred skills
Six Sigma Green Belt, project planning, multi-tasking
Technologies
None stated
Responsibilities
Oversee product quality from assembly to packaging; Champion data-driven decisions to resolve non-conformances and complaints; Interface with R&D and customer quality engineers; Drive quality improvement/automation projects; Perform test method validation and equipment qualification; Support regulatory and supplier audits; Perform data analysis and trending for quality performance; Establish and maintain controlled documentation systems; Supervise quality technical specialists and technicians.
Seniority
Mid-level, hands-on IC
