Our Team

Executive Team

Tim Wells

Founder & President

Cherie Wells

CEO & Managing Director

Sean Boyd

Corporate VP

Rebecca Fuller

SVP, Regulatory Compliance

Junior Villagomez

SVP, Operations

Business Development

Joel Paradis

VP, Business Development

Austin Griffing

VP, Business Development

Consulting Services

Christina Arnt

VP, Medical Device Compliance

Maria Matinog

Senior QA Manager & Audit Program Manager

Recruiting

Jordan Lynch

Senior Technical Recruiter

Eileen Clinton

Senior Technical Recruiter

Communications & Marketing

Shawn M. Schmitt

Communications & Marketing Manager

Amanda Villagomez

Art Director

Accounting

Rob Berlant

Controller

Susie Starr

Finance Assistant

Human Resources

Cindy Ward

HR Director

Tim Wells

Founder & President

Tim Wells, a 24-year FDA veteran, is Founder and President of QualityHub. He has consulted for FDA-regulated industries since 2000, including MedTech and pharma.

Tim began his FDA career in 1976 as a Field Investigator. He worked in the FDA’s Chicago and Atlanta offices for 14 years before moving to Rockville, MD, to work in the agency’s Center for Devices and Radiological Health (CDRH) as a Branch Chief for the Office of Compliance. Tim is perhaps best known for his role as Team Leader for the agency’s Quality System Inspection Reengineering Project, during which he co-authored the QSIT Handbook in 1999. He also played a key role in the development of other highly important FDA documents for the MedTech industry.

Tim has served as a trainer for several educational courses including for the Association for the Advancement of Medical Instrumentation (AAMI), and he has been a speaker or panelist at numerous conferences for the Food & Drug Law Institute (FDLI), the Regulatory Affairs Professionals Society (RAPS), AdvaMed, the American Society for Quality (ASQ), and the Irish Medical Device Association (IMDA), among others.

Further, Tim has published countless articles over the years and has been interviewed dozens of times by media outlets including The New York Times, the Associated Press (AP), The Washington Post, and Ivanhoe Broadcast News, as well as industry publications such as Medtech Insight.

Tim is the recipient of numerous awards, including the FDA Award of Merit (the agency’s highest award) and former US Vice President Al Gore’s Hammer Award for Reinventing Government. In 2008 Tim was listed as one of MD+DI’s 100 Notable People in the Medical Device Industry, and in 2015 QualityHub was recognized by GrowFL as one of its 50 Companies to Watch.

Tim and Cherie Wells founded The Wells Charitable Foundation in 2014. Since then, the foundation has supported more than 50 charitable organizations, contributing to local, national, and international initiatives that empower young people through music and sports, and provide essential programs for teens, women, and veterans.

Cherie Wells

CEO & Managing Director

Cherie Wells is the CEO and Managing Director of QualityHub. For more than two decades, she has guided the consultancy’s growth as a trusted partner to organizations seeking to strengthen quality systems, comply with regulatory requirements, and elevate operational performance.

Cherie’s core philosophy – that education and the disciplined application of quality principles directly improve return on investment – has shaped her career and the services QualityHub provides.

Before leading QualityHub, Cherie completed a distinguished 17-year career with the FDA that saw her hold multiple leadership roles including Quality Director in the Office of Compliance within the agency’s Center for Devices and Radiological Health (CDRH). During her tenure, she developed deep expertise in quality systems, performance measurement, and continuous process improvement. She also served on the FDA’s inaugural Quality Board, managed several multi-million-dollar FDA training contracts, and contributed as an examiner for the Department of Veterans Affairs’ Carey National Award, based on the Malcolm Baldrige Criteria for Performance Excellence.

Cherie’s career also includes roles in education and educational management in private industry, underscoring her lifelong commitment to learning and empowering others through knowledge. Her leadership has been instrumental in advancing QualityHub’s reputation and success, including contributing to the company’s recognition by GrowFL in 2015 as one of its 50 Companies to Watch. She has also been an active participant in the CEO Nexus Roundtable since 2017.

Tim and Cherie Wells founded The Wells Charitable Foundation in 2014. Since then, the foundation has supported more than 50 charitable organizations, contributing to local, national, and international initiatives that empower young people through music and sports, and provide essential programs for teens, women, and veterans.

Cherie holds a Master’s in Quality Systems Management from the National Graduate School of Quality Management in Falmouth, MA. She also completed the University of Maryland’s Business Master’s Program with a Certificate of Technology and earned certifications in Special Education and Primary to High School Education from Carthage College in Kenosha, Wis., and the University of Wisconsin in Parkside. Cherie also holds a Bachelor of Arts from the University of Wisconsin in Madison.

Sean Boyd

Corporate VP

QualityHub Corporate VP Sean Boyd is a 31-year veteran of the FDA who has a passion for assisting manufacturers in adhering to regulatory frameworks, enhancing decision-making processes, and fostering cross-functional alignment – all with an eye toward ensuring that patients worldwide have access to safe and effective medical products of high quality.

Before joining QualityHub in 2025, Sean was Director of the FDA’s Office of Regulatory Programs in the Office of Product Evaluation and Quality (OPEQ), within the Center for Devices and Radiological Health (CDRH). While in that post he was responsible for facilitating a slew of MedTech-focused initiatives with a goal of encouraging robust medical device innovation and an uncompromising focus on patient safety.

Sean filled other top roles while at the FDA, including Deputy Director for Regulatory Affairs in CDRH’s Office of Compliance and leading many components of the center’s Radiological Health Program. He is well versed in all aspects of pre-market, post-market, and compliance regulatory reviews across the full spectrum of medical, industrial, commercial, and consumer electronic products and medical devices.

As a now-retired Flag Officer in the US Public Health Service (USPHS) Commissioned Corps, Sean led preparedness and response efforts that impacted national and global public health policy. His career has taken him to unexpected places including Liberia, where he was Executive Officer of the Monrovia Medical Unit, which cared for Ebola-infected healthcare workers. Sean also responded to natural disasters and other crises in the US and abroad during a stint as Team Commander for a Washington, DC-based rapid medical response team.

Sean holds a Bachelor’s in Biomedical Engineering from Boston University and a Master’s in Public Health from Uniformed Services University in Bethesda, MD.

Rebecca Fuller

SVP, Regulatory Compliance

With more than 30 years of experience in regulated industries, QualityHub Regulatory Compliance SVP Rebecca Fuller oversees client strategic planning for compliance and provides technical support, training, and management of projects and teams to ensure client success and promote initiatives impacting the public health.

Rebecca has been an FDA Field Investigator, a Director of RA/QA for several medical device companies, and a Principal Consultant with specific expertise in risk-based quality systems development and remediation following enforcement actions. She has also led hundreds of audits and inspections of companies that make pharmaceuticals, medical devices, biologics, and combination products.

As a consultant, Rebecca has assisted manufacturers with product development, implementation of risk management programs and risk-based processes, FDA inspection preparation, quality systems development, and validation of a variety of medical products, processes, and test methods.

Rebecca has authored several published articles and spent many years on editorial advisory boards for the Journal of Validation Technology and the Journal of cGMP Compliance. She was awarded Speaker of the Year by the Institute of Validation Technology in 2006 and 2007. And while at the FDA, she was nominated Investigator of the Year and received a Commendable Service Award for her contribution to protecting the public health.

Rebecca holds a Bachelor of Science in Pre-Med/Cellular Biology from the University of Houston.

Junior Villagomez

SVP, Operations

QualityHub’s Senior VP of Business Operations, Junior Villagomez, oversees strategic leadership and operations for the consultancy’s business development, talent acquisition, and comms & marketing teams.

A key QHub leader since 2011, Junior focuses on integrating those core team functions to drive sustainable growth. He aligns QualityHub’s marketing and sales strategies while ensuring that only the highest level of consulting expertise is recruited to tackle the most challenging of client projects.

Junior brings a uniquely diverse perspective to his operational role at QualityHub, built on a career spanning more than two decades. His background includes foundational experience in finance and marketing as well as advertising and creative direction. This blend of analytical and imaginative experience informs his holistic approach to managing operations, developing business strategy, and achieving QHub objectives.

Junior holds a Bachelor of Economics from Rollins College in Winter Park, FL, and is certified to international standards ISO 13485 for quality systems and ISO 14971 for risk management by the British Standards Institute (BSI).

Joel Paradis

VP, Business Development

Joel Paradis is a self-driven business development leader with more than 20 years of experience in sales, management, and project coordination for the MedTech industry and other FDA-regulated spaces. As VP of Business Development at QualityHub, he helps clients strengthen quality systems, navigate complex regulatory frameworks, and achieve sustainable compliance.

Before joining QualityHub, Joel led business development efforts at Oriel STAT A MATRIX, partnering with global medical device manufacturers to meet US and EU regulatory requirements and follow international quality systems standard ISO 13485. He also worked with firms as they prepped for the Medical Device Single Audit Program, or MDSAP, from the International Medical Device Regulators Forum (IMDRF).

Meanwhile, Joel’s earlier roles at SGS North America and BSI Group America deepened his expertise in Quality Management System (QMS) certification, CE-marking, and market access strategy.

Joel holds a Bachelor of Arts in Business Management from Bethel University.

Austin Griffing

VP, Business Development

Austin Griffing has brought to QualityHub nearly two decades of experience in business development, quality assurance, and compliance in the life sciences and technology arenas. He leads strategic growth initiatives as QHub’s VP of Business Development, leveraging his deep expertise in quality systems, risk management, and regulatory compliance to deliver tailored solutions for clients worldwide.

Before joining QualityHub, Austin was VP of Quality, Compliance, and Engineering at Planet Pharma where he oversaw global quality operations and compliance strategies. Prior to that, he was VP of Business Development for US Quality and Compliance at ProPharma; in that role, Austin drove business strategy and partnerships across the pharmaceutical and biotech industries.

Austin’s career foundation was built through progressive leadership roles at Black Diamond Networks and Oxford Global Resources, where he specialized in strategic account management and recruiting, and managed services for life sciences, engineering, and IT. His ability to effortlessly cultivate long-term client relationships has been a longtime hallmark of his work.

With a proven track record in sales strategy, project oversight, quality, and regulatory consulting, Austin is passionate about helping organizations navigate complex compliance landscapes while achieving operational excellence. His industry experience spans pharmaceuticals, medical devices, biotech, IT infrastructure/security, and engineering, making him a trusted advisor for companies seeking innovative and compliant business solutions.

Christina Arnt

VP, Medical Device Compliance

Christina Arnt is a MedTech quality and regulatory leader with 25+ years of experience guiding global medical device organizations through complex compliance challenges. As VP of Medical Device Compliance at QualityHub, she helps companies translate regulatory requirements into effective, audit-ready quality systems that strengthen compliance, accelerate product readiness, and safeguard patient outcomes.

As a consultant and industry leader, Christina has supported makers of MedTech through FDA inspections and enforcement actions, quality system remediations, and the implementation of risk-based, scalable quality frameworks. She’s also guided large, cross-functional teams through periods of regulatory scrutiny and transformation.

Christina’s expertise includes strengthening post-market surveillance, complaint handling, and CAPA systems to enhance compliance, trend detection, and regulatory readiness. Her hands-on approach, informed by years of direct work with industry leaders and regulators, equips her to turn expectations into execution that holds up under inspection and maintains long-term compliance.

Prior to joining QualityHub, Christina held quality and compliance leadership roles at Baxter Healthcare and St. Jude Medical, and at Zimmer Biomet, where she oversaw global corporate quality systems across a broad medical device portfolio. Christina is a certified Lead Auditor and has led and supported hundreds of inspections and audits across global quality management systems, suppliers, and contract manufacturing organizations.

Christina holds a Bachelor of Science in Biochemistry from the University of Wisconsin – Madison and completed her graduate work in Molecular Pharmacology and Experimental Therapeutics at the Mayo Clinic.

Maria Matinog

Senior QA Manager & Audit Program Manager

Maria Matinog, QualityHub’s Senior QA Manager & Audit Program Manager, has vast experience in leading Quality Management System operations, regulatory compliance initiatives, and large-scale audit programs across the life sciences and medical device arenas.

At QualityHub, she oversees end-to-end audit program execution, manages complex consulting projects, and serves as the primary liaison between clients, consultants, and senior leadership. Maria is key in developing audit plans, compiling detailed audit and gap assessment reports, and implementing process improvements that strengthen operational efficiency and regulatory alignment.

Maria brings to QHub deep expertise in GMP- and ISO-based quality systems, including 21 CFR, Parts 210, 211, and 820 for the FDA; ISO 13485 for quality systems; and ISO 14644 for cleanrooms and controlled environments. She is also well versed in ICH guidelines and has been recognized for her analytical approach, collaborative leadership, and commitment to ensuring compliant, efficient, and high-performing quality operations.

Maria’s former leadership roles at Comar and Wuxi AppTec included managing quality teams, leading corrective and preventive action (CAPA) and root-cause investigations, hosting customer and regulatory audits, and driving continuous improvement initiatives. She has a strong track record of building robust systems for document control, environmental monitoring, supplier management, and nonconformance handling.

Maria holds a Bachelor’s in Biological Sciences from Rowan University in Glassboro, NJ, and she is an ISO 13485:2016 Lead Auditor and is CAPM certified.

Jordan Lynch

Senior Technical Recruiter

Jordan Lynch is a results-driven Senior Technical Recruiter and Account Manager with more than 15 years of specialized experience in the Biotechnology, Pharmaceutical, and Medical Device sectors.

At QualityHub, Jordan serves as a vital link between high-level business development and technical execution, ensuring clients have the specialized talent necessary to navigate complex, FDA-regulated environments.

Jordan’s expertise lies in identifying and engaging seasoned consultants to lead critical compliance remediation and Quality Management System (QMS) initiatives. Known by colleagues and longstanding clients for his tenacious mindset and direct approach, Jordan excels at matching subject matter experts (SMEs) to projects involving FDA-483 inspectional observations, warning letters, and system integrations.

His mission is to drive sustainable compliance through “lean resourcing,” delivering the right expertise to ensure business-critical projects are completed on time, within budget, and in full alignment with the highest regulatory standards.

Eileen Clinton

Senior Technical Recruiter

Eileen Clinton is a Senior Technical Recruiter who supports QualityHub’s mission by connecting life sciences clients with highcaliber technical talent that strengthen quality, compliance, and operational excellence across regulated industries.

With more than 15 years supporting regulated life sciences companies – including those in the Medical Device, Pharmaceutical, Biotechnology, and Clinical Research arenas – Eileen offers deep expertise spanning quality, regulatory, clinical operations, validation, manufacturing, and engineering.

Eileen’s recruiting approach is grounded in integrity, precision, and longterm fit, and she specializes in identifying technical, clinical, and regulatory professionals who understand the importance of quality systems, compliance, and patient safety.

Throughout her career, she has partnered closely with hiring managers and leadership teams to deliver talent solutions aligned with stringent regulatory expectations and evolving business needs. Eileen’s background includes building and scaling recruiting teams, launching FDA-focused recruiting verticals, and supporting organizations through growth while maintaining regulatory compliance.

Shawn M. Schmitt

Communications & Marketing Manager

Shawn M. Schmitt is a longtime comms expert, author, podcaster, webinar moderator and developer, and marketer who has created an array of MedTech regulatory, policy, quality control, compliance, and enforcement content since 2005. His extensive experience – including a three-year stint as Executive Editor of Medtech Insight – prepped him for the next stage of his career as QualityHub’s Communications & Marketing Manager.

Shawn served in various editorial roles during his 17 years at Medtech Insight (rebranded from The Gray Sheet and The Silver Sheet in 2016), climbing the ladder from Managing Editor to Deputy Editor, and then to Executive Editor. While at that trade publication, he collaborated with a team to arrange private, customized educational webinars for some of the biggest names in medical device manufacturing. Shawn began hosting and producing a variety of MedTech-themed and marketing-focused podcasts in 2013 that have gone on to rack up more than 100,000 listens.

Shawn’s comms career began well before his work in regulatory and quality journalism. From 2000 to 2003, he led Counseling Today – the American Counseling Association’s flagship magazine – as Editor-in-Chief. He also contributed as an Editor for the UK’s Independent Television News (ITN) network during the 2003 US invasion of Iraq and its aftermath and was a copy editor for The New Republic from 2002 to 2005.

Shawn holds a Master of Arts in Communication: Journalism and Public Affairs from American University in Washington, DC, and a Bachelor of Arts in Journalism and Communications from Point Park University in Pittsburgh.

Shawn has also trained with the CMMI Institute for the quality-systems-focused Medical Device Discovery Appraisal Program (run jointly by the FDA and the Medical Device Innovation Consortium) and has been a Guest Lecturer at UC Santa Cruz.

Amanda Villagomez

Art Director

Amanda Villagomez is QualityHub’s Art Director, bringing 20-plus years of creative leadership to the consultancy.

After earning a Digital Arts degree in 2001, Amanda built a diverse career in advertising, working in digital design, branding, and print across organizations in Miami, Bethesda, MD, and Orlando, FL. Her experience as a visual arts specialist spans myriad industries, including real estate, sports, restaurant, and home products.

Amanda has been with QualityHub since its 2004 launch, first as a freelance designer and later stepping into her longstanding role as Art Director, where she continues to shape the company’s visual identity and creative strategy.

Rob Berlant

Controller

QualityHub Controller Rob Berlant brings more than a decade of experience in accounting, auditing, and finance to the consultancy’s commitment to operational excellence and regulatory compliance. With a strong background in both public accounting and corporate financial management, he contributes to enhancing internal controls, strengthening audit readiness, and improving the accuracy and reliability of financial reporting across the company.

Throughout his career, Rob has gained extensive experience in financial statement preparation, audit coordination, compliance testing, budgeting, forecasting, and process optimization. With a meticulous attention to detail and strong analytical skills, Rob’s work has consistently supported organizations in navigating evolving regulatory environments and meeting the highest standards of financial governance.

At QualityHub, Rob leverages his technical expertise and practical experience to support the consultancy’s daily functions, assess and refine financial processes, and ensure adherence to industry best practices. He collaborates closely with cross-functional teams to drive improvements that align financial operations with organizational objectives and is committed to supporting QualityHub’s mission by promoting transparency, accountability, and sustainable financial practices throughout the organization.

Rob earned both his Bachelor’s and Master’s in Accounting from the University of Central Florida in Orlando and is a licensed CPA in the State of Florida.

Susie Starr

Finance Assistant

QualityHub Finance Assistant Susie Starr has built a diverse career straddling both public and private accounting sectors. In 2006, Susie began working as a Business Manager for a consultant in the medical device and pharmaceutical industries, where she honed her expertise in financial management and operations.

Susie joined QualityHub’s Finance Department in 2020, where she continues to contribute her extensive experience and dedication to organizational excellence.

Susie earned a B.B.A. in Accounting from Hardin-Simmons University in Abilene, Texas.

Cindy Ward

HR Director

Cindy Ward is a strategic Human Resources leader with a proven ability to build people-first organizations in FDA-regulated environments, manufacturing, and professional services. As QualityHub’s HR Director, Cindy partners with senior leaders to shape talent strategy, strengthen policy governance, and drive sustainable performance.

Her expertise includes succession planning, performance management, compliance, and complex employee relations. She excels at translating boardroom strategy into scalable HR programs that attract, develop, and retain diverse talent while minimizing risk. Cindy’s leadership emphasizes collaboration, data-driven decision-making, and a global mindset, ensuring HR aligns with business goals and regulatory standards.

Cindy holds a Master’s in Human Resource Development from Vanderbilt University in Nashville and a Bachelor’s in Exceptional Education from the University of Central Florida. Her career highlights include transforming HR operations at global and regional levels, leading diversity and inclusion initiatives, and delivering measurable improvements in engagement, retention, and compliance.