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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.
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President And CofounderIteam ForwardPittsburgh, Pa, Us -
Vice Chair Board Of DirectorsRqm+ Mar 2022 - May 2023Monroeville, Pa, Us -
PresidentRqm+ Jul 2008 - Mar 2022Monroeville, Pa, UsLeading R&Q mission, vision, culture, and strategies for the organization’s growth and expansion, guiding the executive leadership team and more than 170 employees, internationally. R&Q helps bring more safe and effective medical devices to market for both medical device companies and combination product companies. Leveraging deep industry experience, R&Q provides solutions that help improve the world. Drawing on expertise across the entire medical device product lifecycle, R&Q is uniquely positioned to present a range of strategic and tactical options and execute on the solution that best suits our clients’ individual regulatory and quality needs. Medical Device and Combination Product Services Include:• Regulatory• Quality Systems• Design Assurance• Product Quality• Post-Market Surveillance• Complaint Remediation• CERs• EU MDR -
Director Cv Sbu Regulatory/ Qa/Ra Europe Middle East And AfricaMedrad Jul 2006 - Jul 2008Pittsburgh, Pa, UsI provided regulatory leadership to the MEDRAD (Bayer) Cardiovascular Business Unit as well as leadership for QA/RA in Europe Middle East and Africe for MEDRAD. -
Cv Sbu Regulatory DirectorMedrad Jan 2005 - Jul 2006Pittsburgh, Pa, Us -
Qa New Products ManagerMedrad Apr 1996 - Jan 2005Pittsburgh, Pa, UsI started working at MEDRAD in April 1996 as a Senior QA Engineer working on a prefilled syringe project. I completed all areas of quality for this project (design control, manufacturing quality, sterilization, biocompatibility, verification/validation, packaging validation, etc). I held positions of increasing responsibility in this time frame with the final position prior to becoming a director, being the QA New Products manager. In this role I managed a group of engineers that was responsible for all quality and regulatory items for New Products across all MEDRAD product lines (regulatory, design quality, safety risk management, reliability, quality system impacts, etc).
Maria Fagan Skills
Maria Fagan Education Details
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University Of PittsburghMechanical Engineering
Frequently Asked Questions about Maria Fagan
What company does Maria Fagan work for?
Maria Fagan works for Iteam Forward
What is Maria Fagan's role at the current company?
Maria Fagan's current role is President and CoFounder.
What is Maria Fagan's email address?
Maria Fagan's email address is tf****@****ail.com
What is Maria Fagan's direct phone number?
Maria Fagan's direct phone number is +172432*****
What schools did Maria Fagan attend?
Maria Fagan attended University Of Pittsburgh.
What skills is Maria Fagan known for?
Maria Fagan has skills like Medical Devices, Iso 13485, Fda, Design Control, Quality System, Cross Functional Team Leadership, Quality Management, Product Development, Leadership, Medical Device Directive, Product Launch, Iso 14971.
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