Quality Assurance Engineer
Core
Ensure production processes remain in control and produce medical devices that meet specifications through validation, verification, and compliance activities.
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 tracking, Continuous improvement, Regulatory compliance, Audit support, Process documentation
Preferred skills
Manufacturing engineering partnership, NPI and Lifecycle management, Corrective and preventive action (CAPA)
Responsibilities
Ensure process risk assessment files are in accordance with ISO 14971; Monitor and track non-conformances and lead continuous improvement projects; Partner with manufacturing engineering to optimize inspection and testing methods; Support critical topics such as recalls, production issues, and internal/external audits.
Seniority
Individual Contributor
