Quality Engineer
Core
Implement, maintain, and execute supplier-quality and post-market quality processes for IVD and software-enabled IVD products.
Role type
Quality Engineer (IVD)
Builds
Supplier qualification records, Quality Agreements, Approved Supplier List, and post-market quality metrics.
Domain
In Vitro Diagnostics (IVD) / Medical Devices / Molecular Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier qualification, supplier monitoring, change management, performance monitoring, complaint handling, nonconformance management, deviation management, CAPA support, investigations, quality trend reporting, supplier audit execution, design transfer support, QMS documentation, regulatory compliance (FDA, ISO 13485, ISO 14971)
Preferred skills
ASQ CQA, ASQ CQE, ISO 13485 Internal Auditor, ISO 13485 Lead Auditor
Technologies
QMS standards, FDA quality-system requirements, ISO 13485, ISO 14971
Responsibilities
Partner with Procurement to support supplier onboarding, risk classification, qualification, and performance management; conduct supplier audits and track corrective actions; evaluate supplier-initiated changes for quality impact; execute post-market activities including complaint intake, nonconformance/deviation management, and effectiveness checks; investigate supplier-related quality events; compile quality metrics for trend reporting and management review; draft and maintain quality procedures and work instructions; support audit readiness by organizing objective evidence.
Seniority
Mid-level, hands-on IC