Bradenton, Florida, United States
Medical Device Global Quality & Regulatory Compliance leader successful with leading cross-functional teams for establishing, implementing and integrating quality management systems for design control, design change, quality systems, Corrective Action/Preventive Action, complaint handling, trend analysis, manufacturing, service/support and field actions. Extensive experience in product development and manufacturing quality engineering for complex electro-mechanical, software-driven embedded systems, high volume disposables and applications software in high reliability and human safety critical products from concept to development and distribution. Broad experience in FDA, Competent Authority and ISO Registrar/Notified Body interface including FDA inspections, ISO audits, multiple Warning Letter clearance, Consent Decree, and product regulatory submissions strategy. Skilled at improving product and process quality through continuous improvement using Six Sigma techniques. Experience in Class I, Class II, Class III and implantable medical devices, 510(k) and PMA submissions, and with clinical trial requirements. Proven leader in attracting talent, building organizations, and developing employees. Veteran US Army Officer. • Quality and Regulatory Compliance Strategy • FDA Enforcement Action Turnaround, Remediation and Resolution • Engineering, Quality and Regulatory Technical Proficiency • Continuous Improvement, Lean and Six Sigma Implementation • Multi-Facility and Multi-Geographic Team Leadership • Quality Organizational Design, Enhancement and Sustaining • Coaching, Mentoring and Developing Employees Industry Experience: • Medical Devices: Becton Dickinson, St. Jude Medical, Baxter Healthcare, GE Healthcare, Alcon Laboratories, Abbott Laboratories • Commercial Products: Distributed Processing Technology, Foresight Software, Mentor Graphics, NAC, Texas Instruments • Military: US Army Officer Ordnance Corps
Provides expert Quality and Regulatory Compliance advice to clients.
Provided direction and supported to Quality, Regulatory and Business leaders on significant Regulatory Compliance issues and Quality turnaround situations. Facilitated strategy for 483, Warning Letters and other Regulatory compliance communications, complex requests from Regulatory Agencies, recall strategies, and resolution of Warning Letters and Consent Decrees to define the desired end state for affected elements of the Quality Management System. • Supported key BD Business Unit under Consent Decree to establish and implement QMS-wide improvements • Steered the initiative to comply with regulations, conduct required field actions, and improve complaint handling and regulatory reporting • Established Product Service Quality function which significantly improved service operations and transmission of complaints for regulatory reporting • Restructured CAPA systems to improve investigations, root cause identification, corrective action and documentation • Authored responses to FDA and independent audit observations, coordinated action plans with cross-functional teams and tracked completion of all commitments on time
Quality and Regulatory Compliance functions for $1.1B Urology and Critical Care Division in an FDA-regulated environment through six design and manufacturing facilities with over 250 Quality employees. • Led cross-functional, multi-site teams to resolve FDA Import Alerts at manufacturing plants in Juarez and Nogales, Mexico, including design improvements, manufacturing process, and equipment improvements to ensure products entering the US met specifications through FDA WEAC Lab inspections and tests which led to those products returning to market • Implemented quality system improvements and design changes to support MDSAP, EU MDR, and Brexit, including increased requirements for post-market surveillance resulting in successful FDA, Notified Body and Competent Authority audits • Supported numerous R&D New Product Development and Sustaining Engineering projects with Quality Engineering support to complete design control and design change activities successfully droving multi-million dollar revenue streams • Performed due diligence activities for business development acquisition projects, including an automated urine output system, distribution deals, and a disposable ureteroscope to increase revenue • Strengthened Quality team leadership capability across all design centers, plants, and functions for several positions through diverse interview slates, promotions, lateral moves, and external hiring • Accepted a seven-month assignment supporting a sister division to develop a remediation strategy to resolve compliance issues identified in an FDA Inspection and to establish an environment to lift their Consent Decree
Global quality management systems, quality assurance, quality integrations of acquisitions, and product development quality for $6B St. Jude Medical worldwide, in an FDA-regulated environment with 650 employees. • Developed strategy and led the team to design and initiate the One SJM Business Process Integration Program to establish a single Quality Management System across St. Jude Medical from more than 32 quality systems and ISO certifications worldwide • Launched SJM Development Quality Engineering competency program to improve support of R&D projects and improve employee development and succession plans • Completed due diligence support and subsequent quality system integration of acquisitions and mergers, product manufacturing transfers, and plant shutdowns to ensure quality system compliance and proper records • Managed the successful FDA Pre-Market Inspection preparation activities for an acquisition's new product over six months in Menlo Park, CA, resulting in an FDA inspection completed in three working days and with no 483 observations, which allowed the product approval to launch in the US • Established the Quality Engineer Rotational Program to hire new college graduates and rotate them through a three-year cycle to learn operations quality engineering, development quality engineering, and quality systems to help establish a pipeline for future Quality organization leaders
Quality and Regulatory Compliance functions for the $400M Neuromodulation Division in an FDA-regulated environment through three design and manufacturing facilities with 220 employees. • Directed the remediation efforts to clear the 2009 Warning Letter at the Plano, TX facility • Temporarily assigned to the Sylmar, CA facility to direct the remediation efforts to clear a 2013 Warning Letter • Significantly improved legacy product field performance through continuous improvement and CAPA to reduce key complaints resulting in early explants and recalls • Provided quality engineering support for developing the next-generation platform for spinal cord stimulation and deep brain stimulation products
Global Technical Service Quality for $14B Baxter Healthcare worldwide supporting 68 product families in 37 Baxter-owned depots and workshops plus numerous contracted 3rd party service providers, distributors, and hospital customers. Led depot and field service quality and compliance in an FDA regulated environment with more than 100 Quality employees and three global regions with 30 employees. • Led the Operations and Quality teams at US service centers to complete the corrective actions for all site CAPAs by the end of 2011 • Guided the technical team in developing device log downloader software to capture log events to evaluate complaints and reportable events; distributed it to all Baxter owner service centers, completing a critical FDA commitment • Facilitated team to develop responses to FDA Untitled Letter for a US service center • Managed team to resolve documentation and record-keeping issues for ancillary service events in the service centers located in the US and Puerto Rico and developed common service metrics trend analysis between sites to include primary and ancillary service events • Supported the development of a depot and field service technician software tool to record inspection and test data after servicing to eliminate omissions and errors in datasheets that resulted in product recalls
Global Quality Engineering for a $2B division producing renal dialysis therapy products in a $14B corporation. Led product development design controls, quality engineering, and compliance in an FDA-regulated environment with 30 Quality Engineering employees. • Conducted quality engineering support for Class I and Class II products manufactured in thirty global sites • Provided quality engineering support to develop two new products and numerous sustaining engineering projects • Directed design controls and design change elements for FDA inspection to clear a Warning Letter, including significant Design History File remediation and provided strategic compliance direction for the improvement of other quality systems areas related to Warning Letter re-inspection • Managed quality and regulatory due diligence assessment activities for two merger and acquisition projects.