Robert T Ware Email & Phone Number

Ma, 01824, Us

Support R&D, manufacturing, post market for Defibrillators including new acquisition-mechanical ventilation for QA, RA and Reliability in a cross functional environment; reviewing daily manufacturing issues and providing structured problem solving skills to eliminate issues, interacting with risk based complaints, supporting CAPA and addressing customer needs worldwide. Ability to manage product quality investigations to a successful conclusion, actively reduce product complaints and Out Of Box Failures. Execute risk assessments, collect supporting information and provide recommendations for executive management consideration. Provide support in reportable patient investigations, adverse events and “no fault found” investigations. Collect, analyze, trend and communicate quality data throughout the organization. Feedback closed loop solutions which improves productivity and customer satisfaction.

Initiated Start Up Company.

Monroeville, Pa, Us

Complaint Handling Unit (CHU) member responsible for supporting activities associated with field actions. Recall Investigation Engineer responsible for the oversight and direct support of technical evaluations and investigational tasks required in support of recall investigation(s). Communicate with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable Post Market Surveillance issues.

Implemented Self Audit program to communicate to operator’s correct method for assembly. Quality Systems Engineer responsible for AS9100, ISO 13485 implementation for supplier quality, validation, complaints analysis, ERP implementation, auditing, problem solving, supporting key customers; GE Aviation, Northrop/Grumman, Honeywell, Lockheed Martin, L3, Meggitt and BAE. Certified IPC 600 Trainer.

Kalamazoo, Mi, Us

Creating Start up Stryker NV Processes and Procedures for Supplier Controls, Ship Holds, PIR, Complaints, Field Actions, Management Review, IT Validation Process, Doc Control, Oracle ERP Process, Clinical Returns, Economic Obsolescence and others to ensure compliance to the Federal Regulation and ISO 13485.Integration team member built independent Stryker Neurovascular quality system, reliability analysis, document control, CAPA, SAP and Oracle ERP system, management review reporting and metrics, supplier quality, post market surveillance, clinical programs, auditing, regulatory affairs, complaint handling, design control, in compliance with 21CFR820, ISO 13485, and other worldwide regulations across 96 countries.Developed, Managed and Reported WW Field Action process for Interventional Cardiology, Peripheral Intervention, Neurovascular, Electrophysiology and Neuromodulation divisions across 6 sites and 224 countries. Created 806.10 Medical Device Reports; Reports of Corrections and Removals, Present data at monthly Management Reviews, Maximize and streamline the FA process using Lean Business Processes, and reliability analysis of complaint data. Provided direction and leadership on the development and implementation of post market surveillance tools to assure the business is monitoring product performance vs. predefined risk levels. Used problem solving skills to understand root cause and developed solid corrective action to eliminate potential issues from recurring. Supported internal and external FDA, and acted as SME in regulatory compliance audits. Successfully consulted with high volume of manufacturing sites in FDA preparation and compliance audits, and lifting warning letter.

Marlborough, Ma, Us

Manage and report WW Field Action process for Interventional Cardiology, Neurovascular, Electrophysiology, Peripheral Intervention ,Pheripheral Embolization and Neuromodulation divisions across 6 sites. Create 806.10 Medical Device Reports; Reports of Corrections and Removals, Present data at monthly Management Reviews, Maximize and streamline the FA process using Lean Business Processes across 224 countries worldwide. Provide direction and leadership on the development and implementation of post market surveillance tools to assure the business is monitoring product performance vs. predefined risk levels. Use problem solving skills to understand root cause and develop solid corrective action to eliminate potential issues from recurring. Support internal, external including FDA and regulatory compliance audits as SME. Successfully consulted with large high volume manufacturing sites in preparation for FDA and compliance audits, lifting warning letter. Consulted at the Neuromodulation Division in LA to bring theri post market surveillence program in compliance with CFR 820.

Santa Clara, California, Us

Quality Systems Program Manager, Optical Platform Division, Newark, CA 2004 - 2006Develop and implement compliance assurance to regulatory requirements, and maintained weekly TL9000 quality metrics program for Failure Analysis, RMA, IQA/OQA, MRB, CAPA, internal & supplier audit program, problem solving, and yield enhancement. Responsibilities: supplier management, audit, process validation and qualification. IT Global Data Center Program Manager 2002 - 2003Develop and implement Worldwide Asset Management and Security Registration Process. Created classroom and computer based training material, successfully delivered training and sustaining process. Improved financial accuracy by over 60% initiating revision of Asset Management and Security Registration Process across 9 Business Units. Over 45,000 computing assets registered under this process. Championed the training program, trained 350 employees, including computer based training for the 9 major business units. WW IT organization of 4,000 employees completed training within 9 months. Produced worldwide Data Center statistical audit program and published paper through ISACA Trade Journal. Provided Global Data Center Metrics services to management resulted in reorganization of resources. Quality Systems Program Manager, Systems Manufacturing 1998 – 2002Assured compliance of worldwide SM factory network to meet the ISO 9001:2000 requirements. Technical Advisory Member TAG TC176. Provided audit resource expertise across SM silicon supply chain, and improved supplier quality. $4.3 M annual productivity improvement via scrap reduction. Achieved rework goals of 92, 95, and 96% - 6σBB. Created formalized supplier evaluation process to ensure completion of required audit actions within 90 days. Implemented SBR process to evaluate quarterly status. Regulatory compliance by implementing ISO 9001:2000 quality system improvement across 9 SM sites.

Dallas, Tx, Us

Engineered quality systems throughout semiconductor company with team of 4 direct reports; including total quality management, quality and reliability engineering, assurance, qualification, customer satisfaction, document management, calibration, supplier quality management, environment control. Scope included: design, manufacturing and sales offices worldwide.Upgraded essential quality & reliability systems from informal approaches to world-class methods using networked relational databases that provide data tracking, company corrective action, customer reporting/analysis capabilities.Demonstrated additional $50M in sales over the last 3 years because of improved customer confidence with our quality system. Successfully implemented ISO 9001, QS9000 (ISO 16949), and ISO 14001 Quality Standards. Productivity improvements allowed QOS organization to not hire planned headcount additions 2 years in a row.

Houston, Texas, Us

Corporate Quality Staff member-team of 5 accountable for 108 ISO 9001 registrations worldwide to meet customer requirements. Reported to the Director of Corporate Quality, developed implementation plan, delivered training and ensured compliance of Digital’s Quality System to meet the ISO 9001:1987 standard. TAG TC176 Observing Member since 1989.Successfully managed 15 ISO 9001:1987 registrations worldwide on goal and under budget.Principal Engineer-Worldwide Manufacturing and Logistics program manager for reliability data analysis capability for the corporation. Developed and implemented Reliability Qualification Test program for low end, mid range and high-end computer and network products.Member of DFR team evaluating reliability testing, data analysis, solder joint reliability for BGA assemblies, and solder joint reliability of flip ship and fine pitch SMT assemblies, implemented FMEA program.

Ms, Operations Research, Reliability Eng

Ms, Mathematics Ed

Ms, Biopharmaceutical Domestic Regulatory Affairs