Quality Engineer II
Core
Ensuring compliance, product quality, and continuous improvement across service center and field service operations for medical devices.
Role type
Mid-level IC quality engineer (service & repair)
Builds
Quality systems, validation reports, audit readiness, and corrective actions for service lifecycle
Domain
Healthcare / Medical Devices / Service & Repair Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system compliance, CAPA management, supplier quality oversight, risk assessment, audit coordination, change control, PPAP, root cause analysis, validation/verification support
Preferred skills
ISO 13485 Lead Auditor, ISO 14971 risk management, regulated industry experience, supplier quality processes, continuous improvement methodologies
Technologies
ISO 13485, ISO 14971, PPAP, GMP
Responsibilities
Partner cross-functionally to support quality system compliance; Develop and maintain quality standards and controls; Provide oversight for validation, nonconformance, and CAPA; Investigate quality issues and assess risk; Ensure supplier delivery of quality parts and services; Coordinate change control processes; Conduct supplier audits for GMP/ISO compliance; Monitor and communicate quality metrics; Lead quality walks and track gap resolution; Support internal and external audits; Contribute to continuous improvement initiatives
Seniority
Mid-level, hands-on IC