Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR requirements, and applicable medical device regulations.
Perform quality inspections, product testing, and verification activities to ensure products meet customer specifications and regulatory requirements.
Manage quality documentation and records, including Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), change controls, and quality reports.
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Act as the single point of contact for the Design House, Print Production Manager and Artwork Planners, and to provide timely responses to all inquiries.
Responsible for project management.
Manage client accounts and maintain good rapport with clients.
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