Responsible for all quality related activities: managing quality assurance department of ten plus employees, development, implementation and maintenance of multi-certified quality management system (ISO 9001:2015; AS9100D; ISO 13485:2016 and 21 CFR 820), internal and external auditing planning and execution, internal training, customer relations and liaison for external interested parties , discrepant material control, and top management interaction

Primary Responsibilities:• Developed, implemented, and maintained organizational and departmental quality policies, procedures, goals, and objectives• Collected and analyzed data for determination of goal and/or objective achievement including root cause, corrective, and preventive actions when goal and/or objective not met• Configuration Management of quality management system documentation from concept to obsolescence• Performed in-process and final inspections on materials before and after consumption into product to include first article inspections• Educated employees in the requirements of IPC-A-610 workmanship for all classes

Primary ResponsibilitiesConsult/Train on the ISO 13485:2003 and 21 CFR 820 Quality Management System ImplementationAnalysis of quality management system for compliance to ISO 13485:2003 Medical devives -- Quality management systems -- Requirements for regulatory purpose

Primary Responsibilities:• Developed, implemented, and maintained organizational and departmental quality policies, procedures, goals, and objectives• Collected and analyzed data for determination of goal and/or objective achievement including root cause, corrective, and preventive actions when goal and/or objective not met• Configuration Management of quality management system documentation from concept to obsolescence• Performed in-process and final inspections on materials before and after consumption into product to include first article inspections• Educated employees in the requirements of IPC-A-610 workmanship for all classesKey Achievements• Successful implementation of AS9100 Quality Management System within 6 months of start date resulting in certification. Monetary compensation received for certification audit results. Additional week vacation received for the certification audit results.

Primary Responibilities• Developed, implemented, and maintained organizational and departmental quality policies, procedures, goals, and objectives• Collected and analyzed data for determination of goal and/or objective achievement including root cause, corrective, and preventive actions when goal and/or objective not met • Configuration Management of quality management system and hardware engineering documentation from concept to obsolescence• Established and executed internal audit program reporting to executive management Key Achievements• Productively maintained an ISO 9000 quality management system through the development of management and employee training resulting in 8 surveillance and 2 recertification registration audits resulting in 0 nonconformities. Monetary compensation received for the recertification audit results• Upgraded quality management system to ISO 9001 within 3 months of certification audit to include training of management and employees resulting in certification. Monetary compensation received for the certification audit results• Assisted in the implementation and integration of CMMI Level 3 processes and procedures after the acquisition of Soneticom by DRS Technologies (Signal Solutions) by becoming a member of the existing multi-site implementation team

Responsible for all quality related activities such as quality management system, internal and external auditing, incoming, in-process, and final quality inspections, return material, discrepant material, and top management interaction

Primary Responsibility• Responsible for the expansion of existing systems, the development of new systems and concepts also including product/process validation to ensure products meet with appropriate regulatory/statutory agency requirements, internal company standards and industry current practices.• Assured that products, processes, facilities and systems conformed with quality standards and governmental regulations; conducts internal audits to monitor processes, facilities and systems. • Reviewed and approved operating procedures in Manufacturing and Quality Control departments. Assured that the Equipment Calibration Program complies with the GMPs requirements. Key Achievements• Effectively upgraded ISO 9002 Quality Management System to ISO 9000 to include the integration of ISO 13888 (1385) and FAA:PMA within 1 year period with an outcome of three certifications• Directed/supervised the implementation of ISO 9001 Quality Management System in Fresnillo, Mexico to include the training of management, engineers, and assemblers and without speaking the language within 6 weeks of the opening of the facility• Trained assemblers in Fresnillo, Mexico in inspection, soldering, auditing, ESD, and electronic/mechanical assembly without speaking the language within 6 weeks of the opening of the facility

Developed and instituted process controls for manufacturing and performed data analysisInterfacing with customer and registrar external auditorsDeveloped internal audit practices (system, process, and out of box) as well as performed all internal audits reporting directly to management