Every RQM+ employee from our executive team to our industry-leading thought leaders believes in delivering transformative solutions. Our subject matter experts include notified body leaders, former regulators, and members of committees that draft guidance documents. Our executive team consists of leaders uniquely driving business growth and ensuring client success. Our organization maintains deep industry connections with the FDA, various notified bodies, and health organizations worldwide, allowing RQM+ to be a leading source for current insight and best practices.
Margaret Keegan joined RQM+ in March 2022 with three decades of experience with executive roles at the largest life sciences service providers in the world, including PPD, IQVIA and, most recently, PRA Health Sciences where she was chief operating officer.
Margaret recently served as the chair of CDISC, the global authority defining clinical data and interoperability standards for life sciences and healthcare, and continues to serve on its board.
Prior to RQM+, she served as chief operating officer of PRA Health Sciences (now ICON), one of the world’s largest public contract research organizations and pioneer of digital models in research. Prior to PRA Health Sciences, Margaret served as president of clinical development for IQVIA, the world’s largest healthcare data science company, where she was accountable for the delivery and growth of the clinical development business. At IQVIA, she also served as president of data safety, regulatory, biostatistics and data management.
She is a mathematician and holds a bachelor’s degree in pure and applied mathematics from the University of Strathclyde and is also a chartered statistician.
Lori Smith-Sakalousky joined in 2012 providing technical expertise to RQM+ 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 Chief Operating Officer, her entrepreneurial spirit has guided her to create the RQM+ 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 rounds 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 the success of RQM+.
Lori has held various leadership positions within multiple industries over the past 18 years, including medical devices. Prior to joining RQM+, 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.
Julie Wnek joined RQM+ in 2012 and oversees the financial, IT, and legal aspects of the company. Skilled in project management, Julie has led several successful large programs at RQM+ 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.
As the Chief People Officer, Trisha Trautman leads the Human Resources initiatives at RQM+ 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 patients' lives.
Trisha joined RQM+ in June of 2014 as the first HR professional and has since helped RQM+ grow from 35 employees to over 450. She has established not only the HR foundational aspects for RQM+, 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 RQM+.
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).
Amie Smirthwaite joined RQM+ in March of 2020. A clinical and regulatory affairs expert, Amie has over 25 years of postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. She is leading the RQM+ clinical team, following her role as former Global Head of Clinical Compliance at BSI. Amie developed BSI’s clinical compliance team and led clinical aspects of successful MDR designation.
Joining RQM+ in 2015, Ronnie Mahofski now leads the company through the integration of mergers and acquisitions as the Head of M&A & Managing Director, Fern.ai.
Along with focusing on key strategic initiatives that support the growth of RQM+, Ronnie also provides strategic leadership and tactical execution across all elements of regulatory and quality for medical device and IVD companies.
As Chief Medical Officer, Dr. Daniel Lace leads the RQM+ Reimbursement Division.
Dan frequently serves as a national speaker and educator on managed care programs and technologies, consumer-driven healthcare, emerging medical technologies and trends, healthcare quality improvement, evidence-based medicine and healthcare reform.
Dan has authored numerous articles and has served on the board of directors, medical advisory boards, editorial boards and expert panels for multiple healthcare entities. He has more than 25 years of leadership experience as a healthcare executive across a wide range of managed care, pharmaceutical, device, diagnostic and consulting businesses. He has served as CMO and has held senior leadership positions in global pharmaceutical and medical device companies, as well as national managed care organizations.
As Chief Operating Officer of Trial Services, David leads the RQM+ Clinical Trials division. David has more than 20 years of leadership experience with trial operations, consulting and device research across North America, Europe and Asia-Pacific. He previously served in strategic leadership positions at global MedTech CROs.
Steven Pilewski serves as the chief operating officer for the RQM+ lab services business unit. With more than 30 years of MedTech and pharma expertise, Steve most recently served as vice president of PPD Laboratories’ Good Manufacturing Practices (GMP) lab, which is a division of Thermo Fisher Scientific.
When he began his career at PPD 24 years ago, the GMP lab was a small business with only 50 employees. During his tenure as a member of the executive leadership team, Steve continued to drive the business unit’s global organic growth strategy, transforming it into a leading global analytical services enterprise with more than 3,000 people.
A dynamic sales leader who joined RQM+ in August of 2023, Eric brings more than two decades of sales and business development experience to support current and future growth. Eric holds a unique perspective having spent his career on the side of the customer, including starting his career as a Respiratory Therapist, working in hospitals and sleep disorder centers. Passionate about helping customers, patients, teams and colleagues navigate our ever-changing healthcare landscape, he is focused on providing diverse solutions that help our customers drive measurable results.
Prior to RQM+ Eric held executive sales roles at medical device organizations like Tactile Medical and Philips where he was directly responsible for business development, portfolio expansion, strategy creation and execution and leading sales teams as large as 400+ employees. Eric takes pride in working collaboratively to share ideas, strategies, build alignment with a relationship-focus style built upon trust, transparency and teamwork. He is committed to staying at the forefront of market trends, offering clients tailored solutions that meet their evolving needs and objectives.
GLOBAL BOTTOM CTA INSTRUCTIONS:
To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.
Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!