Quality Engineer I
Core
Ensures compliance with quality systems and regulatory requirements to support product development, manufacturing, and lifecycle activities.
Role type
Entry-level Quality Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes
Domain
Healthcare / Medical Devices / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, statistical analysis, quality standards development, regulatory compliance, documentation management, corrective and preventive actions (CAPA), risk management, cross-functional collaboration
Preferred skills
Manufacturing Execution Systems (MES), Quality Management Systems (QMS), Six Sigma / Lean methodologies, statistical software (Minitab), basic programming/scripting, FMEA, 5 Whys, Fishbone diagrams
Technologies
Minitab, VBA, Python, MES, QMS
Responsibilities
Develop and maintain quality standards and protocols for material processing; collaborate with engineering and manufacturing to ensure quality standards; devise methods for inspecting and testing products and equipment; conduct quality assurance tests and statistical analysis; ensure corrective measures meet reliability standards and documentation compliance; support audits, validations, and risk management activities.
Seniority
Junior, entry-level IC
