Chris Olivier has worked for CCS for over 15 years. He is highly experienced in medical device and pharmaceutical automated system validation and principles of software engineering and programming. He is an expert in assuring compliance with FDA’s Quality System Regulation (QSR) & ISO medical device standards. Experienced in the preparation of technical specifications, requirements traceability software, safety risk management, execution of complex test protocols, and preparation and review of validation documentation to support 510(k) & PMA submissions. Experienced quality assurance engineer, quality systems auditor, project manager and validation specialist.
Chris is also highly experienced in human factors engineering, specializing in usability studies. He has supported many studies that have proven insightful through detailed metrics to enhance future decision making. Calculated responses to user metrics have resulted in an increase to safety and effectiveness, as well as to usability. Resulting actions have also significantly reduced costs and schedules by increasing focus to critical areas of development.