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).