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Role Description:
The Quality System Manager is responsible for managing and maintaining the quality management system (QMS) to ensure compliance with global medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and other applicable requirements. This role oversees internal audits, CAPA processes, document control, supplier management, and supports regulatory inspections and audits. The ideal candidate has strong leadership, analytical, and communication skills, and a thorough understanding of medical device quality systems.
Essential Duties and Responsibilities:
Education:
Required Experience:
Knowledge, Skills,and Abilities:
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