Maria Fagan Email & Phone Number

Maria Co-founded Regulatory and Quality Solutions (R&Q) which has evolved into RQM+ with the purchase of Maetrics. She is a recognized expert in medical device and RA/QA areas.LEADING R&Q STRATEGY, VISION AND MISSION FOR SUCCESS● As President of R&Q she ensures that the business is strategically focused on expansion, growth and that R&Q’s vision, mission and culture are upheld and that the leadership team is poised for success. Maria has an expert understanding of the medical device industry needs and aligns R&Q to fulfill the market need. CULTURE OF HIGH EMPLOYEE ENGAGEMENT AND CLIENT SATISFACTION● R&Q has created a best-in-class culture of high employee engagement and is proud of the consistent client satisfaction with a 90% repeat customer rate. R&Q IMPROVES LIVES● Regulatory & Quality Solutions (R&Q) sets out to improve people’s lives. R&Q provides industry-leading regulatory and quality consulting and engineering services to medical device and combination product companies – bringing more safe and effective products to market. HIGHLY REGULATED INDUSTRY CLIENTS● R&Q services clients in areas of regulatory, quality systems, design assurance, product quality, and post-market surveillance. R&Q is ISO 9001:2015 certified, and offers cost-balanced, scalable, and customized solutions for companies and projects of all sizes. EXPERT IN MEDICAL DEVICE QUALITY ASSURANCE AND REGULATORY AFFAIRS● Prior to co-founding R&Q, Maria held regulatory and quality leadership positions at MEDRAD, a Malcolm Baldrige Award-winner, one of Pittsburgh’s top medical device companies. Previously, she served as Director of Quality Assurance and Regulatory Affairs for all European offices, as well as Manager of Quality Assurance for New Products where she led a team of professionals that provided quality and regulatory services to product development teams. She also holds an Executive Leadership Program Certificate from Carnegie Mellon University Tepper School of Business.

Listed skills include Medical Devices, Iso 13485, Fda, Design Control, and 45 others.

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  University Of Pittsburgh

  Mechanical Engineering