Surgical Sutures, Irradiation Sterilization Qualification Expert Consultant Resume
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Resume of QCF Consultant
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  • Medical Devices
  • Healthcare
  • Manufacturing
  • Finance
  • Communications
  • Automotive

This expert has a B.S. in Mechanical Engineering from the University of Puerto Rico.

Surgical Sutures, Irradiation Sterilization Qualification Expert Consultant Resume
 

This associate is an expert in system integrations, quality assurance and supplier quality engineering, process excellence, and problem solving methodologies.

Specialization includes direct management of irradiation sterilization qualifications, validations and processing, and the execution of quality assurance efforts in manufacturing and packaging operations of disposable medical devices and surgical sutures products.

Validation and compliance experience includes leadership and project management as well as coordination of the validation and installation activities with other consultants, suppliers, engineering firms, and construction contractors.

This consultant is a leader committed to customer satisfaction with a focus on quality as the main enabler for core processes.

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in mechanical engineering, process analysis, quality assurance, surgical sutures and medical device manufacturing / packaging, irradiation sterilization qualification / validation, and related expertise to a wide variety of clients.

 

Qualification /Validation Engineer, Filter Manufacturing Facility, filtration and purification company

Was responsible for qualification document development for drying and annealing ovens used at the manufacturing lines. Coordinated the validation activities, document reviewing. Setup temperature monitoring equipment and software. Developed Documentation for the Equipment Validation Plan, IQ, OQ, PQ and Engineering Studies. Executed the IQ/OQ/PQ protocols.

 

QA Supervisor, Surgical Sutures Assembly Operations, Ethicon LLC (a Johnson & Johnson company), San Lorenzo, Puerto Rico

Was responsible for the Finished Goods Testing Laboratory, supervising 8 Testing QA Technicians and monitoring the flow of product to the contract sterilization facility as well as its final release to distribution centers in conjunction with manufacturing and materials management partners. Team member in the sterilization process transfer from Somerville, NJ to Vega Alta, PR. Was responsible for validations and product adoption into the contract sterilizer system and facility. Primary contact for the Ethicon facility in San Lorenzo for all items related to the sterilization operation. Was responsible for the timely resolution of any exceptions during the Finished Goods testing process as well as any discrepancy at the contract sterilization facility, in close partnership with suppliers involved in the process. Directly supervised twenty-six (26) In-Process QA Technicians in order to monitor their performance, assign priorities and provide training for continuous improvement while fostering team integration and tasks' execution efficiency. Trained in Sterilization Principles and Technologies (Gamma Irradiation, Ethylene Oxide, E-Beam and others).

 

Supplier Quality Engineer, Disposable Medical Device Manufacturer, Stryker, Arroyo, Puerto Rico

Monitored suppliers for in-time and "at-spec." delivery of components. Was responsible for designing the system to monitor "First Pass" supplier yields’ figures. Was responsible for validation of new materials for injection molded components, execution of the IQ/OQ/PQ protocols, coordination of the validation activities. Managed project and supervised personnel. Coordinated inspections with digital vision systems of critical components for confirmation of mold repairs and validations. Defined auditing frequency to maintain direct contact with critical components suppliers. Ensured presence and close follow up of mold status at each supplier.

 

Process Analyst and Consultant, System Integration and Change Management Solutions, Accenture

Enabled new system solutions that ranged from Inventory management software to healthcare bill /pay solutions. Ford Motor Company, Dearborn Michigan – Engaged as a Process Analyst. Evaluated, in conjunction with a team from Ryder Integrated Logistics, a new location for Ford's Standard Parts Warehouses. Delivered three recommendations and proposed supply chain structure of which two were chosen for implementation. Mack Trucks, Allentown, PA – Engaged as Engineering Consultant. Completed the testing and implementation of an Engineering Design Solution that enabled French and American designers to work on components and sub-assemblies simultaneously with "real-time" depiction of changes. BellSouth Communications – Engaged as a Process Design Consultant. In conjunction with a nationwide team of consultants, established the marketing strategies and timeline of deployment for specific campaigns of domestic and commercial applications to be launched by BellSouth in the time when DSL was ramping up as a data transmission solution. Bank of America – Engaged as a Process Consultant. In conjunction with peers from different regional offices; defined, planned and executed new training program for upgraded banking software solutions. Nationwide deployment covered training centers at California, North Carolina; Georgia and Florida. Blue Cross Blue Shield – Engaged as a Process Consultant. Did testing and final implementation of Billing System Solutions for the healthcare client, which allowed physicians to expedite the patients' administrative processes, streamlining and integrating the information for all transactions in a single source for coverage verification, billing and payment.

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FEATURED CONSULTANT

Peter Habicht, Lead Consultant
Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction.

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