Quality System Remediation, Device

Design & Implement Document & Records Control System. Audit Software Development process. Conduct Training on New Document & Records Control system at worldwide sites (Diabetes related Device) for large fortune 500 device manufacturer.

Mr. Bacchus was part of a large team of ex-FDA and industry consultants hired by our firm to conduct audits and remediate our Quality System. Mr. Bacchus was assigned the task of facilitating a team, using six sigma techniques, to remediate the firms Document & Records Control system, as well as Software Quality Assurance practices. Mr. Bacchus did an excellent job facilitating the team to develop a state-of-the-art process, along with a cutting edge approval process, developed using algorithms from DOE matrices. Mr. Bacchus is an exceptional consultant with superb Quality System expertise, communication and training skills.

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