MRC|X is excited to announce that we have expanded our team.
Before joining MRC|X, LLC, Ann spent over 12 years working at Medtronic Spinal and Biologics in both Quality and Regulatory. In Quality she was responsible the management of the quality system including external audits, internal audits, CAPA, training, management review, document control, and change control. In Regulatory she was responsible for establishment registrations, regulatory release of products, post market regulatory assessments, promotional material review, product labeling including electronic labeling, and international registrations.
Ann also worked for Alpha Therapeutics where she authored and executed validation protocols for freezers, refrigerators, document control systems, water systems, immunoassay analyzers, computer hardware, and software. Ann has experience as a field service engineer with Abbott Diagnostics installing and repairing hematology, chemistry, and immunology analyzers in hospitals and physician offices. She started her professional career as a Medical Technologist working in clinical immunology labs at The Regional Medical Center and Methodist Healthcare in Memphis after receiving her Bachelor of Science in Medical Technology from The University of Memphis.
Maris Garner, CTBS, CQA
Before joining MRC|X, LLC in 2016, Maris spent 12 years in different roles within the medical industry including working as a Registered Nurse in the Intensive Care Unit (ICU) of a major hospital, serving as a Clinical Educator for C.R. Bard, Compliance Audit Manager at Medtronic Spinal and Biologics and most recently medical device consulting. While at Medtronic she primarily focused on HCT/P based products regulated under 21 CFR 1271 and 21 CFR 820. She was responsible for developing and maintaining a Quality System, internal and external audits, tissue licensing and registrations, state annual reporting, training programs, interfacing with FDA and state agencies as well as conducting due diligence and integration activities for acquisitions. She gained experience managing HCT/P distribution activities from recovery to customer both directly and as an intermediary.
Maris received a Bachelor of Science in Nursing from Mississippi University for Women. She is a Certified Tissue Bank Specialist through The American Association of Tissue Banks (AATB) as well as a Certified Internal Auditor through the American Society for Quality (ASQ).