Robert Greenleaf Email & Phone Number

Charlottesville, Va, Us

Charlottesville, Va, Us

Charlottesville, Virginia, Us

Responsible for the establishment, compliance and continuous improvement of Contraline's Quality Management System. Partner with cross-functional teammates to enable the design and launch of an innovative male contraceptive device to strategic markets.

Abbott Park, Illinois, Us

Led global, distributed teams in Postmarket Surveillance activities for Cardiac Rhythm Management division (St. Jude Medical). Responsible for leadership of 150+ teammates, accountability and oversight of a holistic Postmarket surveillance system. Accomplishments included dramatically improved (and sustained) key metrics for volume/WIP/cycle time/reporting, greater quality system integration of inputs/outputs into upstream and downstream functions (R&D, Risk management, and Operations teams) and building teammate core competencies and a quantitative method for teammate performance assessment.

Colorado Springs, Colorado, Us

Direct Quality Assurance functions to assure Quality / Regulatory requirements are met including: Postmarket Surveillance, Document Control, CAPA, Internal Audit, Quality Data Analysis, and Learning Management System. Primary source for QMR/Board of Directors/Dashboard reportingSuccesses:- Sourced and implemented a new global Learning Management System resulting in more efficient use of existing resources and reduced training requirements for teammates- Redesigned trending format to include volume, rate and risk analysis measures resulting in increased impact and stakeholder participation - Introduced improved metric dashboards to increase transparency of quality system performance- Led integration activities with newly acquired business resulting in aligned procedures, tools and processes for Postmarket Surveillance, Corrective and Preventative Action and the Learning Management System- Created improved Engineering risk trending capability from PMS function - Improved user and back-office experiences for Agile and Learning Management Systems- Lead gap analysis for newly released 13485 : 2016 regulations for all sites- Developed and implemented new QSR / cGMP training for global teammates

Colorado Springs, Colorado, Us

Led multiple functions at Spectranetics through change management to ensure compliance and continuous improvement. CAPA, Data Analysis and Learning Management System responsibilites added to job role after stabilizing the Postmarket function.Postmarket Surveillance Mgmt:• Led Postmarket team through significant change management.• Responsible for global adverse event reporting (AE - MDR and vigilance) to competent authorities and notified bodies, complaint handling and continuous product improvement by partnering with Engineering teams during failure analysis and trend analysis to drive ongoing product improvement.• Implemented new Postmarket Surveillance database resulting in improved compliance and efficiency while providing more clinical data to internal stakeholdersCAPA/Data Analysis Mgmt:• Responsible for leading the CAPA team and ensuring compliance while contributing to constant improvement• Developed and implemented improved approaches to CAPA triggers and incorporate into periodic trending to support data-driven decision making initiativesData Analysis Mgmt:• Developed and implemented new analysis approaches resulting in the application of data-driven decision making tools across organization. Coached cross-functional departments through adoption of improved approaches. Learning Management System Mgmt:• Responsible for managing the LMS system for global teams

Amsterdam, Noord-Holland, Nl

Direct Philips Healthcare CT/NM businesses through change management, continuous improvement and regulatory realignment in Post-Market Surveillance and associated processes. Team size: 24. Deputy Director function for Radiation Oncology group.• Simplify post-market processes and procedures to facilitate regulatory compliance and workflow efficiency for team of 24 Clinical and Engineering investigators in 4 Global businesses. Impact: From 17 to 0 regulatory findings during 2012 audit.• Plan, direct and execute significant complaint and adverse event reporting remediation projects with multi-platform / global process impact (Approximately 160,000 records). • Implement continuous process improvements by incorporating FDA/GHTF guidance for key Business Units and Global Sales and Service organizations. Result: Improved audit checklists and audit readiness, CAPA investigation results and streamlined high-volume transactional record handling processes. • Prioritize and direct safety and effectiveness improvements to product by driving appropriate changes through Supplier Quality, CAPA, Design and Manufacturing teams based on post-market data analysis and collaborative leadership approach. Result: 80% decrease in Engineering defect submissions product sustainability programs.• Drive positive changes in Key Performance Indicators through the implementation of visual data management and internal audit systems.

Chicago, Us

Lead GE Healthcare businesses in Post-Market Product Surveillance through program leadership and hands-on training. Develop and maintain business strategies that meet applicable global regulations in product improvements, customer care, regulatory reporting, CAPA and recalls/field actions. Recruit, train and retain top-talent staff. Team: 14 quality/regulatory professionals and clinicians.• Developed new internal audit program for Post-Market functions resulting in improved management oversight, new process sustainability and inspection readiness.• Generated new non-conformance assessment for internal audit findings to prioritize risk and determine appropriate solution scope (Correction only vs. CAPA). • Launched new global tools and procedures focused on improving product feedback rates. Result: Significant increase from ~5000 to ~30,000 in customer submitted feedback annually. • Directed new data analysis/metric strategies prioritizing product development, enhanced resource allocation and improved patient safety.• Successfully negotiated with ISO 13485 regulatory bodies (FDA, TUV, BSI, ANVISA) and prepared teams for audit readiness resulting in 0 regulatory findings.

Chicago, Us

Directed global cross-functional management teams to implement business solutions with emphasis on quality improvements including managing internal/external audit results, complaint investigations, supplier corrections, field action reporting and risk management. Optimized quality system processes and delivered global training for improvements. Created metrics designed to drive/monitor improvements and business results to deliver in all relevant reviews.• Reduced open CAPA issues by 50% resulting in systemic process improvements; fewer defects and improved customer satisfaction. • Managed France’s AFSSAPS Quality Program integration under French GRIO Osteoporosis Research initiative.• Improved marketing and service documentation delivery to employees and customers by leading web-based document portal team.

Chicago, Us

Led business development projects and greatly enhanced the product development lifecycle resulting in significant improvements in sales, market share and customer satisfaction. Championed MRI product developments focused on increased usability, improved safety, added features and product differentiation. Collaborated with executive management on executing supply, distribution and acquisition strategies. • Advanced emerging extremity MRI market for Rheumatologists and Radiologists resulting in an install base growth of 500% over 2 years ($2M to $13M in revenue).• Integrated new MRI product into GE product lifecycle infrastructure and drove Lean exercise focused on reducing field DOAs for x-ray products. Result: Defect rate change 25% to 5%.• Trained and coached MRI team of 17 indirect reports (Field Engineers/Managers).

Responsible for the clinical applications training, service training, call-center support and field servicing of x-ray devices for global install base. Selected for project leadership for critical growth and improvement areas as part as my High Potential Development Plan.• Developed and executed training for global Service personnel significantly reducing reliance on 3rd party repair organizations resulting in annual gross savings of ~$2M.• SDS (Service Delivery Span) Champion. Implemented procedures allowing business to monitor and act on 72-hour service goals. Result: net-promoter scores at world-class levels (NPS>80%).• Initiated a “just in time” training inventory system resulting in lead time reduction from 4 weeks to 1 week for training preparation.