Our People

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 has over 30 years of technical and management experience in medical device, IVD, and biologics industries with expertise in quality, program management, training, auditing, and regulatory support.

Her experience spans the entire product life cycle, from design to postmarket. As EVP for Oriel STAT A MATRIX, Kate oversees the technical aspects of the business, providing strategy and managing execution for our portfolio of services.

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.

John Love has 20+ years of experience in training and training development. His expertise includes both US and global regulatory standards, such as MDSAP, EU MDR, FDA QSR, and MDD (93/42/EEC).

William (Bill) Ditty has more than 2 decades of experience as a highly accomplished and results-oriented quality assurance executive, with extensive global expertise in strategy development and deployment, regulatory compliance, risk management, program and project management, and audits and inspections. Prior to working in the medical device industry, quality, and regulatory, Bill served as a commissioned officer in the US Coast Guard.

Bill has years of experience in FDA inspections, quality, and regulatory compliance, including creating a regulatory compliance program and implementing a mock FDA inspection program to proactively remediate issues prior to inspection. He has implemented global quality systems from the ground up (MDSAP, EU MDR, etc.), led transition and remediation projects, and has technical working knowledge of many medical device groups, including software and connected medical devices, orthopedic, neurology, ear / nose / throat, implantables, and radiology.

Throughout his 30+-year career, Ed Siurek has led quality and regulatory departments within the pharmaceutical and medical device industries for both US and international products. He has directed quality and productivity improvement on corporatewide projects in these sectors, spanning 6 continents and 55+ countries. His work has included organizational implementation and oversight of quality management systems, with both primary and direct responsibility for Regulatory Authority interactions. As part of Ed’s role, he has successfully worked with FDA to remediate FDA 483s, warning letters, and consent decrees. He has directed new facility startups and product launches both domestically and abroad. He has led programs and projects serving numerous functions, including medical device product development and launch, ISO 9000 and ISO 13485 certification, EU MDR, quality assurance and regulatory affairs management, Lean/Six Sigma implementation, and global project management leadership, among others.

Yogindra Dellow has two decades of experience in the life sciences field. She is well versed in medical device and pharmaceutical laws and regulations/standards, including FDA 21 CFR 820, 806, and 803; MDSAP; EU MDD/MDR; EU IVDD/IVDR; ISO 13485; and ISO 9001. Her expertise also includes quality management systems, auditing, CAPA, complaint handling, process validation, document control, supplier management, and postmarket surveillance activities.

For Oriel STAT A MATRIX, 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. Yogindra has also played an integral role in developing the Oriel STAT A MATRIX IVDR training course.

Carolyn brings more than 30 years of quality system consulting, development, and management; quality system auditing; and quality engineering experience to each customer engagement.

Carolyn has worked with a wide range of medical device and pharmaceutical manufacturers to create, remediate, and optimize their QMS processes to meet the requirements of FDA regulations, EU MDR/IVDR, ISO 13485, ISO 9001, and other key international regulations and standards. In addition, Carolyn uses her expertise in quality systems training and auditing to help clients effectively implement their QMS processes, review them through internal audit programs, and present and defend them in inspections and audits.

Omar Gonzalez 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) and IVDR (2017/746). Omar also has extensive experience in supporting FDA inspections, 483/Warning Letter responses, and FDA remediation.

Alyssa has nearly two decades of experience in global quality and regulatory for life sciences. Her expertise includes establishing and managing globally compliant quality and compliance systems in a number of regulatory environments, auditing to a wide variety of regulations and standards, and successfully guiding regulatory submissions.