Quality Specialist

Administration & Oversight: Manage QMS processes including deviations, non-conformance reporting, CAPA, change management, supplier qualifications, validation, and risk managementRegulatory Compliance: Ensure compliance with MDR (2020), ISO 13485, FDA's 21 CFR Part 820, and other relevant standardsQuality Assurance: Monitor manufacturing performance, batch reviews, and post-market surveillanceSupport & Collaboration: Provide guidance for design, development, and product launch, collaborate with suppliers, and support continuous improvementDocumentation & Training: Establish and update procedures, approve documentation, and conduct staff trainingVendor Management: Qualify new vendors, maintain agreements, and review vendor performanceRegulatory Support: Assist with lifecycle management of medical devices and maintain regulatory complianceAudit & Accreditation: Support internal audits, participate in audit activities, and maintain ISO accreditation and regulatory approvals
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