Advanced Engineer DQA
Core
Independently setting quality standards, developing testing methods, and managing vendor quality for medical device production processes.
Role type
Senior Quality Assurance Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation for medical devices.
Domain
Medical Devices / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical process control (SPC), experimental design, root cause analysis, CAPA development, supplier quality management, regulatory compliance (21 CFR 820, ISO13485), MS Office Suite
Preferred skills
Device Master Records (DMR) creation, 510K submission support, risk management, design control activities
Technologies
MS Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Manage development and implementation of process control and validation methods; Design experiments to analyze sources of variation; Direct collaboration with suppliers on quality problems and corrective actions; Provide quality expertise in Product Development and Design Control; Coordinate product testing with internal and external laboratories; Lead investigations of non-conformances and develop corrective actions.
Seniority
Mid-to-Senior, hands-on IC