Senior Quality Specialist

The Senior Quality Specialist coordinates and leads activities to maintain the quality management system in compliance with ISO13485, EU IVDR, and 21 CFR 820 requirements. This role involves creating and managing QMS documentation, participating in cGMP activities, and ensuring quality through audits, batch record reviews, and corrective actions. The position requires strong attention to detail, critical thinking, and risk-based decision-making to support continuous improvement and regulatory compliance.