QA Engineer
Core
Oversee QA support activities, product quality from assembly to packaging, and compliance with Quality Systems and regulations.
Role type
Quality Engineer (Manufacturing)
Builds
Ensures product specifications and quality requirements are met through testing, validation, and process improvement.
Domain
Medical Device Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS), CFR Part 820, ISO 13485, test method validation, installation qualification, data analysis, CAPA management, audit support, team supervision
Preferred skills
Six Sigma Green-Belt, project planning, scheduling inspection/testing activities
Technologies
None stated
Responsibilities
Plan and coordinate QA support activities; oversee product quality from assembly to packaging; champion data-driven decisions for non-conformance resolution; interface with R&D and customer quality engineers; perform test method validation and correlation studies; support regulatory audits; establish and maintain controlled documentation systems; supervise quality technical specialists and technicians.
Seniority
Junior to Mid-level, hands-on IC
