Medical Device Quality Manager

Job Summary Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams. Key Responsibilities Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs. Support FDA inspections and regulatory audits. Drive quality remediation and compliance initiatives.