Senior Quality Engineer
Core
Lead structured problem-solving, interpret technical drawings, and drive continuous improvement for manufacturing quality compliance in medical devices.
Role type
Senior Quality Engineer (Manufacturing)
Builds
compliant medical device products and validated processes
Domain
Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
structured problem-solving, root cause analysis, CAPA implementation, validation data review, risk assessment, ISO 13485/QMSR compliance, failure analysis, technical drawing interpretation
Preferred skills
people management, project management, cross-functional collaboration
Technologies
ISO 13485, QMSR
Responsibilities
Lead structured problem-solving and provide engineering quality recommendations; Investigate manufacturing defects and implement corrective actions; Review and approve validation and test data; Support internal audits and ensure regulatory compliance; Provide technical mentorship to junior team members; Collaborate with cross-functional teams and suppliers to resolve quality issues
Seniority
Senior, hands-on IC with mentorship