Creating Connected Infight Experiences for Today and the Future Managed product quality issues through nonconformance reduction and corrective actions (CAs). Participated in technical reviews, status meetings, and new product qualifications. • Successfully lead internal & external CAs, thus ensuring timely implementation & effectiveness. • Dispositioned nonconforming material (MRB) while ensuring conformance to requirements. • Colaborated with engineering, manufacturing, and supply chain on issues related to Quality, OTD, and FA (Failure Analysis). • Reviewed and approved DCOs, ECOs, and deviations using the Product Lifecycle Management (PLM) software, thus proactively managing changes.• Supported KPIs data analysis as a basis for monitoring and managing improvements.

Marvin Engineering Co. is a global leader in the manufacture of missiles carriage and release equipment for the Lockheed Martin F-35 ProgramSupported the F-35 Integrated Project Team (IPT) quality function by working in a cross-functional environment. Collaborated with program management, engineering, operations, and inspection to ensure program quality per the SQM Appendices QX and QJ/QCS-001 requirements.• Provided manufacturing quality assurance for the F-35 mission critical bay adapters, ejectors, rail launch systems, and air-to-air & air-to-ground pylons.• Lead corrective action activities to determine root cause and corrective/preventive measures to eliminate deficiencies, and reported on status of action items.• Participated in material review board (MRB) & dispositioned nonconforming material using SAP quality notifications (QN’s).• Reviewed manufacturing planning work instructions, methods, and process specifications as they related to assuring product quality.

Meggitt is a global engineering group specializing in smart sub-systems for aerospace, defense and energy markets with over 1100 employees in U.S. and international locationsProvided technical support and monitored Boeing Defense customer quality to reduce customer escapes, and to ensure compliance with the D6-82479 requirements.• Performed assigned responsibilities in customer quality assurance with specific focus on RCCA execution and six sigma/lean methodology projects, to sustain improvements.• Responsible to lead root cause corrective action (RCCA) and update command media procedures as appropriate.• Performed contract reviews to ensure customer quality clauses flow down, and verified that the source inspection documentation was acceptable prior to shipping.• Lead and participated in cross-functional team efforts for failure investigations and reports.• Interfaced with supplier quality to facilitate problem resolutions, hence optimized information and material flow.

Honeywell Aerospace is a $10B+ Strategic Business Group with 40,000 employees in over 125 domestic and international locationsImproved supply chain operations by providing technical support for receiving inspection, manufacturing, and customer escapes. Utilized lean & six sigma to attain best in class performance and sustain business results.• Provided supplier quality for incoming rejects, on line rejects, and engineering investigations.• Maintained SAP inspection plans & ensured quality stops removal, to optimize the workflow.• Prepared periodic SAP reports on quality issues for assigned program or product area(s).• Supported Production Part Approval Process (PPAP) for new programs, to ensure flow down of supplier quality clauses.• Measured Airbus A350 quality performance KPI’s per the Airbus AP1013 GRESS/ASR requirements as a basis for monitoring and managing improvements, and updated the dashboard metrics.

Injection Molding Manufacturer, OEM ComponentsManaged the quality assurance department and quality systems to ensure product quality, process performance, and compliance to customer and regulatory requirements. Interfaced with customers and suppliers in matters related to quality. Supervised ten people. • Quality systems planning and management to ensure compliance to ISO 9001:2008.• Responsible for management reviews, 3rd party audits, and supplier management processes. • Administered the CAPA system, quality systems audits, and customer complaint resolution.• Responsible for management of the MRB, SPC, and IQ / OQ / PQ process validations.

Global Infusion Systems DCOEPartnered with regulatory and compliance departments to ensure product quality, performance and safety, and conformance to regulations. As a Compliance Representative ensured training and compliance to corporate policies & procedures and reported on the monthly quality metrics.• Participated in the Change Control Board (CCB), design reviews, design verifications and validations, and FMEA’s activities in a cross-functional team environment.• Performed supplier quality audits and provided feedback on risk management activities to ensure compliance to ISO 14971.• Contributed to meeting regulatory and technical goals and minimized time to market through leading the design transfer activities.

New Product Development, Infusion SystemsEstablished and maintained a suitable and effective quality management system using FDA CFR 21 Sub-Part 820, cGMP, ISO 13485, and other applicable regulations. Accomplished organizational goals through effective planning, organizing, and leading of organizational resources.• Established the quality system procedures & processes, flowcharts, and quality forms.• Processed Engineering Change Orders (ECO) leveraging design principles to meet strategic goals of high reliability product design and lower warranty costs. • Maintained the Design History File (DHF) and sustained the quality organization by collaborating with other departments on quality processes.

Manufacturer and Service Provider for Infusion SystemsProvided document control coordination, maintained corrective actions database, internal audits, and customer complaint files while reporting to the VP of QA & Regulatory. • Maintained the integrity of the quality system during change control by keeping the latest revisions in the design history file and device master record files.• Managed production schedule through an MRP system, equipment calibration schedule, and performed batch reviews.• Participated in the Materials Review Board (MRB), external audits, coordinated CAPA activities and supported receiving inspection activities.