Quality Engineer II
Core
Ensuring compliance, product quality, and supplier quality for global service and repair operations in the medical device industry.
Role type
Quality Engineer II (Service & Repair)
Builds
Quality systems, validated processes, and compliant supplier networks for service centers and field operations.
Domain
Medical Devices / Healthcare Technology / Quality Engineering
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, process validation, nonconformance management, root cause analysis, quality metrics reporting
Preferred skills
ISO 13485 Lead Auditor, ISO 14971 risk management, regulated industry experience, supplier quality processes, equipment/process validation, continuous improvement methodologies
Technologies
ISO 13485, ISO 14971, PPAP, GMP, ISO
Responsibilities
Partner cross-functionally to support quality system compliance and operational objectives; Develop, implement, and maintain quality standards and controls; Provide oversight for validation, verification, and CAPA processes; Investigate quality issues and assess risk; Ensure supplier delivery of quality parts and services; Coordinate change control and audit readiness; Monitor quality metrics and improvement opportunities; Lead quality walks and facilitate gap resolution; Manage Supplier Action Requests (SAR) and SCAPA; Support internal and external audits; Contribute to continuous improvement initiatives.
Seniority
Mid-level IC