Quality Control Laboratory Manager
Current• Committed to follow and assure conformity to FDA 21 CFR 820, EU Directive MDR 2017/745 and ISO 13485/9001 Quality Standards • Compliance Champion, ensuring strict conformity with regulations, overseeing documentation, and managing NCRs, CAPAs, and Certificates of Analysis (CoAs).• Team Leadership guiding a team of testers and staff in sample processing, ensuring precision and adherence to standards.• Continuous Improvement by contributing to procedural enhancements, managing calibration systems, and performing equipment and process validations (IQOQPQ) to drive changes and improvements.• Regulatory Readiness through collaborating with the quality manager for audits and certifications, supporting corrective actions and internal audits to improve the Quality Management System.• Training and Development to enhance team competence through comprehensive training programs.• Change Management by facilitating smooth transitions, including process changes and improvements, with a focus on documentation and data control.• Customer Satisfaction as addressing CAPAs, customer complaints, and product investigations with performance reporting.• Regulatory Expertise providing guidance on complex regulatory matters as needed.• Dedicated to upholding high-quality standards, fostering a culture of excellence, and ensuring both customer satisfaction and regulatory compliance.