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R&Q exists to improve the lives of patients, our clients, and our team members. We primarily do this by offering companies of all sizes industry-leading regulatory and quality support. But that's hardly the end of it...

 

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Mission

R&Q provides regulatory and quality solutions that accelerate the success of medical device companies and improve people's lives. We exist to promote economic growth through regional partnerships, to provide a rewarding place to work, and to improve our communities. 

Vision

R&Q will become a world-wide leader in providing full service regulatory and quality solutions, increasing revenues by becoming internationally known for providing exceptional business balanced leadership that has proven to accelerate medical device companies and improve people’s lives.  


R&Q's story and executive team

Core Team 1Maria Fagan and Lisa Casavant met while working together at Medrad in 2004. High quality medical device consultants were hard to come by in Pittsburgh and they found themselves venturing to other states to find them. Talking with local medtech development organizations and medical device startups confirmed what they already knew: the lack of local support was an issue. Taking matters into their own hands was the only solution.

Maria and Lisa cherished Medrad's culture and high standards for quality; the company was a two-time winner of the Malcolm Baldridge National Quality award, presented for performance excellence by the President of the United States. When Maria and Lisa decided to start their own firm, they committed to bringing the very best of Medrad's culture to their new company and combine it with their own industry experience. The intention was simple: offer the highest quality regulatory and quality engineering services to the device community possible.

More than 10 years later, R&Q has grown to almost 200 employees, five major offices, and over 300 clients with whom we partner to solve the most challenging regulatory and quality system issues. Most importantly – and proven by client feedback – the quality of our work hasn't been sacrificed since day one.

Maria Fagan   /   Cofounder and President

Fagan_SquareMaria co-founded R&Q in 2008 and has been focused on business balanced growth from inception. Maria ensures that the R&Q business is strategically focused on growth and that R&Q’s vision and mission are upheld and R&Q is poised for success. Having worked at R&Q since the beginning, Maria has an expert understanding of the consulting industry as well as the medical device Industry. Maria has nearly 30 years of Industry experience in medical device development across RA/QA areas, as well as post-surveillance and compliance. Maria capitalizes on this experience to ensure that R&Q continues to provide top quality strategic and tactical solutions to the Industry. Prior to co-founding R&Q, Maria held positions at MEDRAD a Malcolm Baldridge winning company and one of Pittsburgh’s top medical device companies. Maria’s previous positions included Director of Quality Assurance and Regulatory Affairs for Europe, as well as Manager of Quality Assurance for New Products where she led a team of professionals that provided a broad range of quality and regulatory services to product development teams. Maria holds an Executive Leadership Program certificate from Carnegie Mellon University’s Tepper School of Business and a B.S. in Mechanical Engineering from the University of Pittsburgh.

Lisa Casavant   /   Cofounder and Chief Strategy Officer

Lisa_SquareLisa co-founded R&Q in 2008. At R&Q, Lisa initially focused on providing regulatory expertise, Consulting Services leadership, large client sales and account management. Over time, her primary responsibilities have shifted toward providing strategic guidance across the company, analyzing market dynamics and overseeing the regional and international expansion of the business, as well as directing key customer accounts. Lisa has nearly 20 years of industry experience, with extensive expertise in medical device RA/QA, and business development. Prior to co-founding R&Q, Lisa held positions at MEDRAD and the Tyco Healthcare Retail Group. Lisa’s previous positions included Senior Regulatory Affairs Specialist at MEDRAD, where she focused on worldwide submissions for product development teams and field safety risk assessments for product issues, and Process/Quality Engineer at the Tyco Healthcare Retail Group. Lisa holds an M.S. in Mechanical Engineering from the University of Delaware and a B.S. in Mechanical Engineering from West Virginia University.

Julie Wnek   /   Chief Financial Officer

Wnek_SquareJulie joined R&Q in 2012 and oversees the financial, IT, and legal aspects of R&Q. Skilled in project management, Julie has led several successful large programs at R&Q including most recently the re-design of the Business Development process and the implementation of the new ERP system. On a day to day basis, Julie is intimately involved in customer contract negotiations, profitability analysis, cash flow management, and short/ long term business, financial, and tax planning. Julie’s career includes eight years of progressive financial planning & analysis and corporate development roles at MEDRAD, including global strategic planning, business unit financial management, portfolio optimization, and M&A financial modeling. She assisted with setting pricing strategy for new products, led product line closures from a financial perspective, and established a corporate-wide process for new product development financial decision making. Prior to MEDRAD, Julie gained Big 4 Accounting experience as an Auditor with KPMG. She holds an MBA from the University of Pittsburgh with a Marketing concentration and a B.S. in Accounting from Saint Vincent College. Julie is an active CPA, has served as an adjunct Accounting Professor at Saint Vincent College and Westmoreland County Community College, and been a member of the Westmoreland County 4-H Board of Directors.

Lori Smith-Sakalousky   /   Vice President of Consulting Services

Sakalousky_SquareLori joined in 2012 providing technical expertise to R&Q’s clients while focusing internally on employee leadership and development and the strategic growth of the Consulting Services infrastructure. Combining her strong technical skills with empowerment and compassion, Lori leads by example and has routinely demonstrated an ability to bring out the very best in her teams. Under her leadership, Lori’s team has been consistently given, on average, 9+ on a scale of 10 for client satisfaction with a 90% repeat customer rate. As Vice President of Consulting Services, her entrepreneurial spirit has guided her to create the R&Q operational model with a focus on people, process and tools. She has focused on operational excellence while ensuring the global scalability of the Consulting Services infrastructure. Lori is responsible for developing and monitoring the consulting services team’s strategic goals, current objectives and overall operating budget. Her team consists of technically skilled consultants providing industry leading regulatory and quality consulting and engineering services along with program management expertise. The design and delivery team round out the consulting services team and is responsible for proposal development that focuses on successful delivery of services. Lori’s outstanding leadership and her ability to focus and direct teams towards accomplishing specific and measurable goals has been one of the backbones to R&Q’s success. Lori has held various leadership positions within multiple industries over the past 18 years including medical device. Prior to joining R&Q, Lori was with MEDRAD and while there, led her team to Industry Week’s Best Plants and AME Manufacturing Excellence Awards. Lori earned a B.S. in Business Administration with a concentration in Psychology from Clarion University. She also earned an MBA from Chatham University, an Executive Leadership Program certificate from Carnegie Mellon University’s Tepper School of Business and is a Six Sigma Green Belt. She has served as guest speaker at Saint Vincent College via the Kennametal Center of Operational Excellence.

Juli Denny   /   Vice President of Sales and Marketing

Juli_SquareJuli is a proven team leader, mentor and motivator with demonstrated success driving sales, marketing, and business growth. A natural leader with core competencies including growth strategy development and execution, sales force development and management, and marketing planning and execution. She is an award-winning sales, marketing, and business development professional with a record of achievement markedly improving the sales of healthcare products and services for consulting firms and medical device industry leaders. Since she joined the team in late 2016, Juli leads all sales and marketing functions within R&Q. Juli has been fully focused on developing and executing on strategic sales and marketing plans that set up R&Q for immediate and long-term growth. Sales team members, sales process, metrics, and targeting have been improved and expanded. Marketing outreach, thought leadership, and marketing tools have become hallmarks of R&Qs brand. R&Q achieved record sales growth of over 60% in 2018. Juli has over 20 years of experience in sales; all within the healthcare industry. Starting in pharmaceutical sales with Johnson and Johnson for 7 years, then spending the last 13 years in medical device services sales including regulatory affairs, quality systems, full product development, R&D, and engineering services. Juli’s long-term areas of expertise include service-provider sales, medical devices, and sales leadership. Juli has a B.A. from The University of Michigan and holds an MBA from Augsburg University.

Trisha Trautman    /   Vice President of People and Culture

Trisha_SquareAs the Vice President of People and Culture, Trisha leads the Human Resources initiatives at R&Q by establishing the HR strategy which includes a strong culture where top talent is engaged in meaningful work, feels significant and confident and is passionate about improving patient’s lives. Trisha joined R&Q in June of 2014 as the first HR professional and over these 5 years she has helped R&Q grow from 35 employees to over 170. She has established not only the HR foundational aspects for R&Q, which includes talent management, employee relations and benefits, but has also led and assisted with many strategic company initiatives. Trisha has over 20 years of experience in Human Resources and has spent much of her career in medical devices working at Respironics (now Philips Healthcare), as well as other industries including Government Consulting and Nuclear. She also founded and ran her own Human Resources Consulting Company prior to joining R&Q. Trisha holds a B.A. in Business Administration from Washington and Jefferson College and an M.A. in Industrial and Labor Relations from Indiana University of Pennsylvania. Trisha is a nationally certified Senior Professional in Human Resources (SPHR).

R&Q is a proud member/sponsor of the following organizations

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Note: If you are interested in applying for a position at R&Q, please visit the careers page.