Our People

Chad Hedlund - President

Chad joined Oriel STAT A MATRIX in January 2016 and has served as President of the company since January 2021. He provides the overall business leadership for Oriel STAT A MATRIX’s consulting and education services, with a focus on strategic planning and managing Oriel STAT A MATRIX’s key client relationships, partnerships, and global deployments. Chad is committed to maintaining the company’s heritage of serving our clients with industry-leading competency development capabilities while providing the skilled quality and regulatory resources needed to successfully design, develop, manufacture, distribute, and support high-quality medical devices.

Chad’s experience in life sciences quality management systems and regulatory compliance spans over two decades and includes quality, regulatory compliance, technical, and leadership roles at companies such as Medtronic, Boston Scientific, and Guidant.

Kate Leith - EVP, Life Sciences Consulting and Education

Kate is responsible for ensuring that Oriel STAT A MATRIX’s Body of Knowledge is up to date with rapidly changing regulatory requirements and includes the tools and topics our customers need in order to stay competitive in a quickly evolving industry landscape.

Kate brings over 25 years of experience in global quality, compliance, and learning and development in the life sciences sector to Oriel STAT A MATRIX.  Her expertise spans the total product life cycle, including design development, premarket quality, operations and supplier quality, and postmarket surveillance. Kate’s strategic focus on emerging technologies and regulatory changes have enabled Oriel to be at the forefront of helping our clients navigate the ever-changing medical device landscape. Kate’s deep knowledge of regulatory and quality topics – coupled with her keen understanding of developing user-friendly and relevant training content – ensures that Oriel STAT A MATRIX’s training library is the best in the industry.

Silvia Vasquez - VP, Seminar Sales

Silvia leads the Seminar Sales team. Her primary responsibility is to support device manufacturers’ employees satisfy FDA and international regulatory requirements through our courses.

Silvia brings over 20 years of experience supporting hundreds of professionals, including senior leaders, to accelerate their impact and influence. She believes that hiring and developing the right people in the right roles, create long-term business success. Silvia has successfully supported BPOs, sales and learning/ development organizations globally to bridge the leadership and management challenges that arise from running multinational operations.

Silvia is a certified coach and holds a M.S in Industrial/Organizational Psychology.

Sarah Haverin - SVP, Business Development

Sarah joined Oriel STAT A MATRIX in 2015. Since that time, she has worked with a wide range of clients to help them achieve their global RA/QA objectives. With a focus on supporting manufacturers to develop sound strategies for bringing products to market as well as strengthening ongoing compliance initiatives, Sarah takes a client-focused approach to ensure the needs of all stakeholders are accurately captured. As SVP of Business Development, Sarah provides leadership to the business development team. In this capacity, she ensures that the team provides best-in-class support to Oriel STAT A MATRIX’s clients as the global RA/QA environment continually evolves.

Sarah holds a Bachelor of Science degree with a triple major (Molecular Biology, Microbiology, Genetics) from Monash University and an MBA from Texas State University. Sarah has almost 20 years of experience ranging from laboratory science and R&D to tertiary education and professional services sales.

Alicia Hemphill - VP, Regulatory Affairs

Alicia provides technical oversight for Oriel STAT A MATRIX’s regulatory affairs practice, focusing on the firm’s US-based customers.

Alicia’s regulatory experience spans over two decades in negotiating and bringing medical devices from concept through to commercialization. She is responsible for two IDEs, two PMAs, nine original 510(k)s, more than twenty-plus direct FDA and NB Q-Sub negotiations, five design dossiers, and multiple approvals in Canada, China, Japan, Latin America, and Australia. In her most recent role before joining Oriel STAT A MATRIX, Alicia led the EU MDR gap assessment activities within her organization, successfully placing the company on the path to compliance.

Oriel STAT A MATRIX’s customers cite Alicia’s ability to identify, develop, and solve complex regulatory and organizational challenges as the key to their successful outcomes.

Alicia holds an MS in Engineering Technology.
 

Richard Vincins - VP, Regulatory Affairs

Richard is based in the UK and leads global regulatory affairs projects for our international customer base. He also ensures that Oriel STAT A MATRIX and our affiliates are well positioned to support global customers through the EU Medical Device Regulation and In-Vitro Diagnostic Regulation transitions. Richard brings over 25 years of global medical device, IVD, and pharmaceutical QSR experience to each customer engagement, employing his extensive expertise in submission content, regulatory classifications, risk management, software-driven products, postmarket surveillance, complaint handling, adverse event reporting, inspection readiness, and auditing.

Richard is responsible for over 30 FDA 510(k) clearances across 10 different branches. He has been involved in EC certification for 62 technical files covering 30 different project types, varying from Class I through III.   

Richard holds a BS degree in Biomedical Biology. He is a voting member of ISO US Technical Advisory Groups (TAG) 176 for Quality Management Systems (ISO 9001) and 302 for Auditing Management Systems (ISO 19011).

John Love - VP, Learning and Education

John has over 20 years of training and course development experience that spans production management, quality and regulatory training, document control, root cause investigation, and internal auditing. His diverse background equips him with practical knowledge that enhances the classroom training experience. John is passionate about developing and delivering training at a high level to ensure not only that learning objectives are met during classroom time, but also that lessons learned are maintained and applied back to the job.

William "Bill" Ditty - VP, Quality Management System Consulting

Bill spearheads many of our most challenging QMS implementation and consulting projects. His depth of knowledge working for startup and multinational medical device companies gives him a unique perspective on the compliance challenges facing manufacturers. Most recently Bill served as Vice President of Quality Assurance and Compliance for Orchid Orthopedic Solutions, overseeing all QMS and regulatory compliance activities for a company that specializes in high-risk implants and instruments.  Prior to Orchid he held senior level QA positions with Monteris Medical and Stryker.

Bill holds two Bachelor’s degrees from the United States Coast Guard Academy and an MBA in Finance from Old Dominion University.

Christine Park - Director, Quality Training and Consulting

Christine Park is a solution-focused and results-oriented professional with a wide array of experience spanning more than 30 years in medical device and IVD regulatory affairs, quality systems, and training.  A former director of quality assurance, she has an MBA and a BS in medical technology and has served on the working groups authoring ISO 13485:2016; ISO 14971:2019 and ISO/TR 24971:2020; and ISO 20416:2020 (postmarket surveillance). Chris brings a pragmatic and common-sense approach to help organizations design and establish good practices and achieve regulatory compliance.  

Joseph Silvia - Director, Software Consulting and Education

Harlow Thielke - Director, RA/QA Consulting

Harlow brings over 20 years of experience to each customer engagement whether as an instructor or as an auditor. From time spent as a college professor to conducting audits in the life sciences sector on a wide array of standards and regulations (including ISO 13485, ISO 9001, and 21 CFR 820) for major device manufacturers, Harlow brings passion, experience, and practical knowledge to each Oriel STAT A MATRIX training class. He also provides his expertise to companies across the globe as a consultant, with a focus on quality management systems (premarket, production, postmarket) and 510(k) submissions. 

Gene Redig - Director, Quality and Regulatory Consulting

Gene is responsible for software and quality management systems (QMS) projects at Oriel STAT A MATRIX. He brings over 25 years of medical device, biotech, and high-tech sector experience to our international customer base. 

Gene is a results-driven and people-oriented professional with a proven track record in quality management, regulatory affairs, cross-functional project management, and business operations. He excels at driving leading-edge technology-based solutions from both internal and external points of view. He has hands-on experience with software development, risk management, quality systems, FDA/ISO regulations, qualification/validation, FDA/ISO auditing, CAPA, MDSAP, GCP, usability engineering, and the new EU IVDR and MDR.

Gene holds a BS for Computer Science and an MBA. He has ASQ certifications as a Certified Quality Manager (CQM), Certified Software Quality Engineer (CSQE), and Certified Quality Auditor (CQA).

Irena Canedo - Director, Quality and Regulatory Consulting

Omar Gonzalez - Director, Quality Auditing and Consulting

Omar has over two decades of medical device and diagnostics RA/QA experience in the US, EU, Canada, Australia, Japan, Brazil, and China, working at companies such as Boston Scientific, Beckman Coulter, and Danaher, as well as serving as an auditor for SGS North America. His Notified Body and industry expertise includes serving as a Lead Auditor in auditing to FDA QSR, ISO 13485, MDSAP, and EU MDD/MDR/IVDD/IVDR, as well as assisting organizations to build quality management systems that are in full compliance with a variety of standards and regulations, including EU MDR (2017/745). Omar also has extensive experience in supporting FDA inspections, 483/Warning Letter responses, and FDA remediation.

Yogindra Dellow - Director, Quality and Regulatory Consulting

Yogindra has two decades of experience in the life sciences field. She is well versed in medical device and pharmaceutical laws and regulations/standards. She has served as a Response Team Lead for FDA and Notified Body remediation activities regarding EU MDR or vigilance trends, Medwatch inquiries, FDA 483s, and recall reports.

Yogindra has supported a wide range of medical device manufacturers to understand both the new EU Medical Device Regulation and the EU In Vitro Diagnostics Regulation.  Customers value her direct approach and expansive knowledge of the regulations.

Alyssa Schwartz - Director, Quality and Regulatory Consulting

Alyssa has nearly 20 years of medical device and IVD experience spanning the entire product life cycle for global submissions, product launch, operations, auditing, quality system development, managing global inspections, and remediation. She has facilitated FDA Warning Letter and 483 mitigation and has experience with USFDA, CMDCAS, ANVISA and EU Competent Authorities. 

Alyssa leverages her extensive background and real-world experiences to ensure that customers obtain both a transparent audit evaluation and consultative engagement.  Because of Alyssa’s involvement with a broad range of product designs and QMS processes, she is quickly able to use a relevant real-world example to support customer success.

Alyssa holds a MS in Bioscience Regulatory Affairs from John Hopkins University and a BS in Microbiology from the University of Pittsburgh.

Ed Siurek - Director, Quality Consulting

Ed leads quality system design and development projects for Oriel STAT A MATRIX. He also oversees all audit services for our customers, including mock MDSAP audits, supplier audits, and baseline and preassessment 13485/9001/QSR audits. Ed has more than 20 years of experience in practical, hands-on application of quality standards, process and continuous improvement, facility and supplier audits, and regulatory compliance in both the pharmaceutical and medical device industries. Ed has supported life sciences organizations on 6 continents and in more than 55 countries, giving him a unique perspective that allows him to easily perform and succeed in diverse environments.

Ed holds an MS in Information Systems Management from the Keller School of Management in Cleveland, with a concentration in Project Management. He also earned a BS from Purdue University in West Lafayette, IN. He is a certified Six Sigma Black Belt.

Carolyn Tomlinson - Director, QMS Training

Carolyn oversees our auditor courses and manages the firms relationship with Exemplar Global, the accreditation body for these courses. Carolyn brings more than 20 years of quality system development and management, quality system auditing, and quality engineering experience to the classroom. Her work experience has been in various industries, including medical device and pharmaceutical products, nonwoven materials, electronics, publishing, and polymer rigid film production. Carolyn leverages her diverse background and real-world experiences to ensure that students obtain a practical understanding of classroom topics. Students consistently comment that Carolyn’s involvement with a broad range of manufacturing technologies helps to personalize and enhance their learning experience.  

Carolyn holds a BS from Virginia Tech in Chemical Engineering with a minor in Chemistry. She is a certified Six Sigma Black Belt.

Gina Abudi - VP, Program Management

Gina provides project management guidance and direction for our complex engagements. She has more than 25 years of experience in project management and has served a wide array of industries.