Quality Control Administrative Assistant (Medical Devices)
Documentation & Compliance Admin : Managing, organizing, and archiving Quality Management System (QMS) documents, device master records, and inspection logs.
Batch Record Review : Checking device batch records, certificates of analysis (CoA), and inspection reports for accuracy and complete compliance before release.
Non-Conformance Tracking : Logging product non-conformances, customer complaints, and CAPA (Corrective and Preventive Action) reports, following up with production teams for updates.
Audit Preparation : Assisting the Quality Assurance team with internal and external audit preparation, gathering compliance data, and updating regulatory checklists.
Supplier Quality Tracking : Assisting with supplier quality evaluations, logging raw material compliance documents, and tracking supplier performance metrics.
Medical Device Quality Control Experience (Must-Have) : Hands-on experience specifically in quality control and regulatory compliance for medical devices.
Fluent English : Exceptional written and spoken English skills for precise documentation and daily communication with technical and regulatory teams.
Extreme Attention to Detail : Meticulous approach to reviewing technical paperwork, compliance documentation, and medical device standards without missing details.
Proactive Ownership : A self-motivated administrator who follows up on open quality issues, manages tasks independently, and maintains continuous progress.