Quality Engineer 2 - SinglePort Da Vinci
Core
Quality Engineer supporting product development and operations from concept through commercialization for medical devices, ensuring compliance with design control and regulatory requirements.
Role type
Quality Engineer II (Medical Device)
Builds
Medical devices (SinglePort Da Vinci system)
Domain
Medical Device Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control, Risk management, Process validation, Root cause analysis, CAPA, pFMEA, Statistical analysis (ANOVA, DOE), GMP/ISO/FDA compliance, Technical documentation, Change management
Preferred skills
Data visualization (Tableau, PowerBI), Advanced degree
Technologies
SAP, Trackwise, Agile
Responsibilities
Support manufacturing and cross-functional teams to resolve technical problems; Monitor project priorities and communicate status; Implement and police GMP, ISO, and FDA requirements; Support internal and external audits; Design and implement inspection and testing methods for products and equipment; Author technical documents; Provide statistical support for manufacturing and product development.
Seniority
Mid-level, hands-on IC
