Bringing a Class III, minimally invasive implant, and reversible treatment for BPH to market. www.clinicaltrials.gov (NCT04987138)- Company Head of Quality, Management Representative- Ensure Quality System compliance with FDA QSR, ISO 13485 and EU MDR requirements- Evaluate existing Quality System for enhancements and optimization- Establish and monitor company quality objectives- Manage Quality resources, including personnel, equipment, and budget in alignment with corporate goals- Perform Management Reviews and advise top management of any product or process related issues and recommendations for improvements- Plan and manage internal audit program and appropriate corrective actions- Manage quality assurance activities, ensuring effective product development and quality system processes

Helped to bring Continuous Glucose Monitoring with a modern app over-the-counter. Learn about how your body's metabolism responds to food and exercise habits at hellolingo.com• Provided Quality Engineering leadership in direct support of the product lifecycle• Managed activities and development of QA Eng team• Provided QA guidance and leadership to org• Provided influential peer leadership with partner sites to drive proactive quality improvements• Assessed, monitored, and revised resource needs to assure appropriate level of quality support and competencies• Oversaw multiple portions of the Quality System, including but not limited to Design Controls, Product Changes, Product Release, NC/CAPA, and Supplier Quality

At Enzyme, I leveraged deep knowledge of the industry to manage the operations and product development of the eQMS which streamlines documentation and integrates with tools customers already use. We guided clients through their entire regulatory and compliance lifecycle, from product design and development, to both pre- and full- submissions, to post-market compliance. I'm passionate about enabling innovation and bringing technology to market faster and more efficiently, toward the ultimate goal of improving patient outcomes.

Building a modern Quality Management System.

Quality Core Team Member / Quality Program Manager role leading team which successfully executed design verification and validation testing on a Class III endovascular thoracic aorta implant that received IDE approval with no conditions.Thoracic (Valiant™ Evo / Valiant Navion™) Aortic Aneurysm Stent Graft System, andEndovascular Abdominal (Endurant™ Evo) Aortic Aneurysm Stent Graft System

Responsibilities at Boston Scientific steadily increased in scope and complexity (from R&D Engineer to Sr and later Prin Quality Engineer). Worked in new product design and development, led 510(k) design changes, assumed R&D and Quality Core Team member leadership roles, and led project-specific contract manufacturer supplier quality management activities. Was responsible for the development of product specifications, test methods, risk management documentation, SOPs, and quality agreements with contract manufacturers. Regularly collaborated with and influenced all core team and QMS functions.Last role with BSC included a variety of quality systems subject matter expert (SME) responsibilities, from site Document Control and Training to CAPA Coordinator, to Internal Audits, Quality Plan ownership, Management Review, and audit back room manager. Revised and maintained numerous procedures within the Quality Management System. As a CAPA SME, mentored CAPA Owners throughout the phased CAPA process. Also conducted various training, including CAPA and electronic data and training management systems. Alair™ Bronchial Thermoplasty System

Expect™ and Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needles

Ultraflex™ Esophageal NG and Tracheobronchial Stent SystemsExtractor™ Pro Retrieval Balloon CathetersAdvanix™ Biliary Stent with NaviFlex™ RX Delivery SystemInjection Gold Probe™ and Gold Probe™ Bipolar Hemostasis CathetersAutotome™ RX Cannulating SphincterotomeJagtome™ RX Cannulating SphincterotomeStonetome™ RX Cannulating Sphincterotome

MES implementation prep: led and completed SIPOC evaluations in Pharm-Filling Business Unit

Medical instruments/aids barcode database creation and implementation for use in operating room during surgeries