Stephanie Rallis-Daw is the Founder, Owner and Principal Consultant at Rallis Consulting LLC, a management consulting, project management and healthcare consulting firm. With over 17 years of experience in her career, she is highly skilled in quality engineering, quality control, quality assurance and quality management system (QMS) implementation, as well as maintenance and continual improvement, regulatory submissions and regulatory compliance.
Known for her strategic, tactical approach, Stephanie is passionate about her work and loves helping her clients to continuously improve, meet their company objectives and bring disruptive, innovative devices to the market. She oversees the QMS for medical device companies to establish, maintain and continually improve the adequacy, suitability and effectiveness of overall the QMS. Stephanie also helps to prepare organizations for domestic and international inspections, including and audits and product launches. She mentors project teams on statistical techniques, DV&V, equipment qualifications, regulation and standard updates, and guides them through process validation, investigations and other risk management scenarios.
After earning a bachelor’s degree in Biology with a pre-med emphasis from The Master’s University, Stephanie went on to become a Certified Biomedical Auditor, Certified Quality Engineer and Certified Medical Device Lead Auditor with a scope of EU Medical Device Regulation, ISO 13485 and regulatory compliance audits, and looking ahead plans to complete an executive MBA and become RAC Devices and ACRP-MDP certified.
Based in San Clemente, California, Stephanie volunteers in her community with Sydney Cooper Senior Smiles, Orange County Animal Rescue, and Family Assistance Ministries. She credits her success to focus, drive, giving back, perseverance, great mentors and most importantly hard work.
International Society of Female Professionals Member Stephanie Rallis-Daw, ASQ CQE, CBA can be found on the Association Directory, where she is looking forward to networking with you.