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Our People

A team with practical experience.

Oriel STAT A MATRIX's consulting and training services stand on a firm foundation of knowledge and real-world experience. Our team includes more than 130 experts in performance excellence, regulatory affairs, product manufacturing and testing, quality management, quality assurance, GMP compliance, and program management.

Their expertise allows them to identify issues, clarify needed decisions, and balance your business needs with compliance requirements.

Oriel STAT A MATRIX team members are based in more than 18 countries, and they speak a wide range of languages.   


Key members of our team:

  • Alan Marash

    Alan Marash - CEO

    Alan focuses on strategic planning and managing Oriel STAT A MATRIX’s key client relationships, partnerships, and global deployments. Alan is committed to maintaining the company’s heritage of driving performance improvement, with the goal of helping customers reach the highest levels of success and profitability.

  • Chad Hedlund

    Chad Hedlund - Sr. Vice President, Life Sciences Consulting and Education

    Chad provides the overall strategic leadership for Oriel STAT A MATRIX’s Life Sciences Consulting and Education services. His focus is on guiding our customers to a successful market entry of their product (e.g., medical device, IVD, or combination product) while also building and optimizing our customers’ quality and regulatory compliance functions in a manner that balances shareholder, customer, global regulatory, and employee needs. Chad’s experience in life sciences quality management systems and regulatory compliance spans nearly two decades and includes quality, regulatory compliance, technical, and leadership roles at companies such as Medtronic, Boston Scientific, and Guidant.

  • Kate Leith

    Kate Leith - Vice President, Training and Education

    Kate develops and updates Oriel STAT A MATRIX’s public and on-site Life Sciences training classes. She also serves as an instructor. Kate has more than 25 years of experience in the medical device and biologics industries, serving in technical, management, and training roles at companies such as Beckman Coulter and Sanofi Diagnostics.

  • Ed Siurek

    Ed Siurek - Vice President, Quality Consulting

    Ed supports Oriel STAT A MATRIX’s Life Sciences consulting services. He specializes in process and continuous improvement, strategic operational planning and implementation, training, coaching, and regulatory compliance. Ed has more than 20 years of experience in the pharmaceutical and medical device industries, including positions at The Linde Group, Innovision Radiation Measurements, and Lafayette Pharmaceuticals.

  • Richard Vincins

    Richard Vincins - Vice President, European Union Regulatory Affairs

    Richard provides regulatory compliance and product submissions support for medical device manufacturers around the world. He has more than 25 years of experience in the medical device industry, with expertise in ISO 13485, US FDA QSR, and the requirements of other countries, including Canada, Japan, and Brazil.

  • Lori Kahler

    Lori Kahler - Vice President, United States Regulatory Affairs

    Lori supports US-based companies seeking FDA product approval/clearance and serves as an instructor. She has more than 25 years of domestic and international experience in multifunctional RA/QA for the medical device and biotechnology industries. Her experience includes a unique blend of expertise in competitive intelligence gathering and strategy development. She ensures the competent evaluation and implementation of product market pathways that are both compliant and cost-effective.

  • Carolyn Tomlinson

    Carolyn Tomlinson - Director, Quality Management Systems Training

    Carolyn manages the company’s core auditing courses, and she is a popular instructor. Her expertise includes FDA, MDD, and Canadian Medical Device regulatory compliance; RA/QA training development and delivery; audit conduct and management; quality systems; and performance improvement initiatives. She has more than 20 years of quality engineering experience, including working at Bausch + Lomb and Hitachi Electronic Devices.

  • Ernani Pires

    Ernani Pires - Vice President, Performance Excellence

    Ernani facilitates quality and productivity improvements using fact-based decision making to achieve key organizational objectives. He draws on more than 40 years of experience in quality management systems and performance improvement methodologies. Before joining Oriel STAT A MATRIX, Ernani was the first US President of SGS ICS – one of the largest Certification Bodies in the world.

  • Michele E. Jackson

    Michele E. Jackson - Director, Affiliate Relations

    Michele recruits and maintains relationships with Oriel STAT A MATRIX’s affiliate consultants. He brings 25 years of talent acquisition, staffing augmentation, and business development experience to the team. Most recently, he was a senior talent acquisition consultant for a global pharmaceutical, medical device, and biotechnology firm. 

  • Gina Abudi

    Gina Abudi - Vice President, 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.

     

Our team is here to help. Call 1.888.532.6360 or contact us online ›