Quality Assurance Engineer
Core
Ensure production processes remain in control and produce medical devices meeting specifications through validation, verification, and compliance activities.
Role type
Quality Assurance Engineer (Medical Devices)
Builds
Medical devices
Domain
Medical Devices / Manufacturing (via careerplan.io/jobs/R5027433-quality-assurance-engineer-at-envista)
Required skills
ISO 14971 risk assessment, validation and verification, root cause analysis, non-conformance tracking, regulatory compliance, process optimization, audit support, continuous improvement
Preferred skills
NPI lifecycle management, manufacturing engineering partnership, corrective and preventive action (CAPA)
Technologies
ISO 14971, NPI, CAPA
Responsibilities
Ensure process risk assessment files comply with ISO 14971; oversee robust validation and verification cycles; partner with manufacturing engineering to optimize inspection methods; monitor and track non-conformances; lead continuous improvement projects; consult on regulatory standards and documentation; support recalls, audits, and production issues; drive root cause analysis for production non-conformances.
Seniority
Mid-level, hands-on IC
