Quality Management Systems Consultant@Quality System Consulting & Contracting (www.qsc2.com)
Verified
Experienced QA/RA and Quality Systems executive with over 20 years of experience leading regulatory compliance, design controls, and risk management across multiple global medical device organizations. Proven track record of driving measurable improvements, including a 47% reduction in non-conformance reports, while successfully managing FDA and ISO audits with zero findings. Experienced in developing and optimizing quality management systems, implementing corrective and preventive actions, and ensuring full compliance with ISO 13485, IEC 62304, and other regulatory standards. Adept at leading cross-functional teams, fostering collaboration between engineering, product development, and operations, and translating complex regulatory requirements into actionable strategies. Recognized for leveraging data-driven insights to enhance process efficiency, improve product quality, and deliver high-impact solutions that align with organizational objectives and business goals.More...