Maria Fagan

Maria Fagan Email and Phone Number

President and CoFounder @ Iteam Forward
Pittsburgh, PA, US
Maria Fagan's Location
Greater Pittsburgh Region, United States, United States
About Maria Fagan

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.

Maria Fagan's Current Company Details
Iteam Forward

Iteam Forward

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President and CoFounder
Pittsburgh, PA, US
Employees:
2
Maria Fagan Work Experience Details
  • Iteam Forward
    President And Cofounder
    Iteam Forward
    Pittsburgh, Pa, Us
  • Rqm+
    Vice Chair Board Of Directors
    Rqm+ Mar 2022 - May 2023
    Monroeville, Pa, Us
  • Rqm+
    President
    Rqm+ Jul 2008 - Mar 2022
    Monroeville, Pa, Us
    Leading 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
  • Medrad
    Director Cv Sbu Regulatory/ Qa/Ra Europe Middle East And Africa
    Medrad Jul 2006 - Jul 2008
    Pittsburgh, Pa, Us
    I 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.
  • Medrad
    Cv Sbu Regulatory Director
    Medrad Jan 2005 - Jul 2006
    Pittsburgh, Pa, Us
  • Medrad
    Qa New Products Manager
    Medrad Apr 1996 - Jan 2005
    Pittsburgh, Pa, Us
    I 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

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 Quality Auditing Fmea Regulatory Submissions Sop Iec 60601 Supplier Quality Dmaic Change Control R&d Biomedical Engineering Six Sigma Root Cause Analysis 21 Cfr Part 11 Fda Gmp Lean Manufacturing Commercialization Spc Manufacturing Engineering Minitab Continuous Improvement Biotechnology Glp Ce Marking Lifesciences Iso Design Of Experiments Design For Manufacturing Quality Control Process Simulation Revenue And Profit Growth Quality Systems Failure Mode And Effects Analysis Employee Engagement Award Winning Culture Growth Strategies Combination Products Strategic Vision

Maria Fagan Education Details

  • University Of Pittsburgh
    University Of Pittsburgh
    Mechanical 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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