Job Details
Skills And Tools:
Job Description
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.
Job Requirements
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.
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