Quality Engineer 3
Core
Ensures quality of finished medical device products (da Vinci Surgical System) and supports manufacturing operations by identifying and resolving quality issues across electrical, mechanical, and software subsystems.
Role type
Quality Engineer (Medical Devices)
Builds
Medical device product lines (da Vinci Surgical System platforms, endoscopic instrumentation, accessories)
Domain
Medical Devices / Surgical Robotics
Required skills
Root cause analysis, risk analysis, process validation, regulatory compliance (FDA, ISO 13485), data analysis, engineering change control, SOP development
Preferred skills
Agile/ACCS, SAP, internal/external audits, complex electromechanical devices
Technologies
SAP, ACCS
Responsibilities
Develop and validate quality assurance procedures and sampling plans; Monitor manufacturing procedures for compliance; Evaluate deviations and non-conformances; Support process validation and verification; Review and trend quality issues using data analysis; Respond to quality escalations and provide technical support; Perform risk analysis for variance requests; Release process changes via engineering change orders; Escalate patient safety or surgical efficacy issues.
Seniority
Mid-level (1-5 years experience)