QA Labeling Specialist
Core
Generate, review, and approve QA labeling documentation, lot-specific production labeling, and Instructions for Use (IFU) to ensure compliance with global health and safety standards for medical products.
Role type
QA Labeling Specialist
Builds
Production labeling documents, IFU templates, and technical data libraries for medical diagnostic products.
Domain
Medical Diagnostics / In Vitro Diagnostics (IVD) / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microsoft Word, Excel, Adobe InDesign, NiceLabel Pro, regulatory documentation review, change control processes, technical data management, library management, workplace safety compliance
Preferred skills
FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR EU/2017/746 knowledge
Responsibilities
Generate and approve QA labeling documentation, review lot-specific production labeling, populate and approve IFU templates, upload documents to technical libraries, process updates via ETQ, collaborate on build and change control projects, maintain clean and orderly work areas
Seniority
Mid-level, hands-on IC