Senior Quality Assurance Engineer I (temporary)
Core
Conducts complex studies to solve novel technical problems, manages risk analysis, and ensures quality system compliance for medical device manufacturing.
Role type
Senior Quality Assurance Engineer (Medical Devices)
Builds
Medical devices and quality management systems
Domain
Medical device manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management, supplier quality audits, nonconformance analysis, engineering change notifications (ECNs), quality system implementation, statistical methodologies, Six Sigma, lean manufacturing, regulatory knowledge (21 CFR 820, ISO 13485)
Preferred skills
MasterControl, SmartCAPA, Oracle, Crystal, deviation handling, CAPA experience
Technologies
MasterControl, SmartCAPA, Oracle, Crystal
Responsibilities
Conduct conceptually related studies for novel technical problems, coordinate risk analysis and management activities, review and approve Engineering Change Notifications (ECNs), mentor and evaluate Quality Auditors and Engineers, evaluate and select suppliers via performance monitoring and audits, review nonconformance records for root cause and corrective actions, ensure containment of nonconforming product, maintain quality management system effectiveness, participate in design and development activities, support Internal and supplier audits.
Seniority
Senior, hands-on IC with mentorship duties