•Quality Professional with 36 years business experience in Medical Devices.•Extensive experience in Regulated Industry Requirements (FDA, QSR, ISO, EN) with Class I, II, and III Medical Devices. (Johnson & Johnson Products, Ethicon, Johnson & Johnson Medical, Ethicon Endo Surgery, Johnson & Johnson Quality and Compliance Services, Medtronic Neuromodulation, Medtronic Cardiac Rhythm Disease Management, Stryker Instruments) •Experienced in developing and implementing Quality Systems in rapidly growing, highly competitive markets to meet Regulatory and Customer Requirements.•Proven record of identifying, coaching, mentoring, and promoting high potential talent.•Proven track record in preventing, mitigating, troubleshooting, or solving Quality issues by providing new or innovative solutions to meet Regulatory and Customer needs.•Experienced in multi-site / multi-national operations.•Proven developer of High Performing, Interdependent Teams.•Demonstrated Quality leadership in the integration of acquired or merged franchises.•Experienced Professional in Quality Sciences in the areas of Quality Systems, ISO, Quality System Regulation, Statistical Techniques, and Process Excellence (Six Sigma).Specialties: Medical Devices (Class I,II,III)ISO Regulations for Medical Devices (ISO 13485 - version 2016)FDA Regulations (21CFR Part 820)
Listed skills include Fda, Medical Devices, Iso 13485, Quality System, and 39 others.
