Quality Assurance Engineer
Core
Ensure production processes remain in control and produce medical devices that meet specifications through validation, verification, and risk assessment.
Role type
Quality Assurance Engineer (Medical Devices)
Builds
Medical devices
Domain
Medical Devices / Manufacturing
Required skills
Risk assessment (ISO 14971), Validation and verification, Root cause analysis, Non-conformance management, Continuous improvement, Regulatory compliance, Audit support
Preferred skills
Manufacturing engineering partnership, NPI and Lifecycle management, Training and process implementation
Technologies
ISO 14971, NPI, Lifecycle Management
Responsibilities
Ensure process risk assessment files are in accordance with ISO 14971, Partner with manufacturing engineering to optimize inspection and testing methods, Monitor and track non-conformances, Support critical and time-sensitive topics such as recalls and audits, Support the creation and continuous improvement of Quality Assurance processes
Seniority
Mid-level, hands-on IC