Wayne Mayberry 22145 Pheasant Street, Lake Forest, CA 92630 (949) 246-3813 wm13cad94@westpost.

net PROFESSIONAL EXPERIENCE *Trimedyne Incorporated - Lake Forest, CA 2007 - 2009 Manufacturer of medical surgical lasers and delivery systems Regulatory Compliance Specialist -Managed and executed the product Complaint Handling System by interfacing with cross-functional representatives, tracking of trend analysis, and initiating cor rective actions. -Initiated Med Watch reports as required. -Improved the product complaint system by decreasing the open time for complaint s by at least 20%. -Supported Manufacturing for documentation accuracy by reviewing manufacturing w ork orders and verifying corrective actions as required. -Administered Corrective and Preventive Action (CAPA) investigation to determine cause of high rejection rates of key product components. *Parental Caregiver 2006 - 2007 -Performed care-giving tasks for late elderly parents including: providing trans portation, shopping, appointment scheduling, etc. -Attended workshops on resume writing, job search strategies, etc from Right Man agement *Edwards Lifesciences - Irvine, CA 1995 - 2006 Medical manufacturer of late stage cardio-vascular disease solutions. Engineer II / Medical Mfg. Tech. -Designed & validated medical device manufacturing equipment used in the testing of components according to strict FDA regulations. -Performed and lead FMEA (Failure Mode Effect Analysis) task teams. -Performed equipment and process validations for quality and manufacturing equip ment used in a state of the art Heart Valve Manufacturing Facility while collabo rating with Manufacturing Engineers, Regulatory Affairs, and R&D. *Baxter Paramax Systems - Irvine, CA 1989 - 1995 Manufacturer of high through put blood and urine laboratory analysis equipment. Senior Engineering Technician -Performed testing and validation of equipment according to FDA regulations whil e collaborating with Manufacturing Engineers, Regulatory Affairs and R&D. *Baxter Edwards Labs - Irvine, CA 1989 - 1995 Manufacturer of IV and Enteral infusion pumps. Engineering Technician -Performed testing on programmable infusion pumps. -Evaluated customer return pumps sent for repair, when required sent for repair and providing monthly report results to Management on any possible design issues . VALIDATION EXPERIENCE Performed software validation of prototype pulse oximeter and firmware changes to production released pumps. Performed black box and system validations to proposed firmware revisions to ass emblies on laboratory blood and urine analysis systems. Developed, validated and released to production methods for the calibration of a nd procedures for use of bar code reader used for the receiving inspection of pr inted barcodes. Performed validation of resistance welder used in the welding of components used in the manufacturing of tissue heart valves. Development & Validation of wire testing process for the receiving inspection

of incoming Elgiloy(TM) wire used in the manufacturing of tissue heart valves de creasing testing time by at least 25%.. Developed specifications (hardware and software) and performed validations for n ew high through-put wire tester Validated manufacturing & inspection test equipment for the on-time approval by the FDA of a state-of-the-art tissue heart valve manufacturing facility by desig ning, preparing and executing protocols (IQ / OQ / PQ) while working with Manufa cturing Engineering, R&D, Regulatory and other internal customers. EDUCATION - 3 plus years - Computer Science & Engineering Classes (80 + units), National U niversity, Costa Mesa, CA & California State University Long Beach, Golden West and Orange Coast College. - Electronic Technology Certificate (Orange Coast College, Costa Mesa, CA) - Biomedical Technology Certified - Southern California Institute of Technology - Anaheim, CA 2010 TRAINING & CERTIFICATIONS - ASQ Certified Quality Technician - Medical Device Certification (Coastline ROP) - FDA regulation (21 CFR) & ISO13 485 - Obtained training in Level 1 Eddy Current Testing (ETS-100) from Uson. VOLUNTEER EXPERIENCE - Biomedical Technician Volunteer - West Anaheim Medical Center 11/15/10 to pres ent - Assisted Biomedical Manager (Andy Armenta) with the performance of PM (Pre ventative Maintenance) & calibration of onsite hospital equipment.