
alix oe
columbia, maryland
About
Board of Director at Capitex International/TWIDCO, Inc Quality and Regulatory Leader
united states
columbia
medical devices
six sigma, spc, fmea, lean manufacturing, design of experiments, supplier quality, iso 9000, quality control, supply chain management, quality auditing, validation, reliability engineering, reliability, cmmi, engineering management, internal audit, electronics, manufacturing, engineering, product development, program management, root cause analysis, quality system, quality management, quality assurance, continuous improvement, dmaic, failure mode and effects analysis, statistical process control
Experience

director of quality
first source electronics

columbia, maryland

board of director
capitex international/twidco

quality manager
nova bioenergy
* Manage and accountable for all quality issues and quality deliverables including quality budget, * Develop the quality and reliability requirements for all incoming material and finished products. * Development and management of quality and process improvement programs. * Coordinate yield/data reporting and conduct, SPC, trend analysis of process, quality data and metrics for suppliers and in-house manufacturing using Minitab Software. * Work with Purchasing for suppliers to improve quality, reduce costs and maintain on-time deliveries * Collaborates with design engineers and manufacturing engineering by participating in risk analysis, design FMEAs, process FMEAs, DOE, and Capture and enforce Customer’s CTQ * Design, oversee, manage and participates in quality system projects, and improvement projects * Manage Several Project Improvements, develop and mentor all quality personnel including Lower level quality engineers and inspectors as well as other quality associates. Results: The Company has obtained ISO 9001 Certification for the first time

senior quality manager
theragen
Oversee the Quality Program including Quality Engineering, the Quality Management System based on FDA 21 CFR Part 820, ISO 13485 requirements, MDD 93/42/EEC, and the Canadian Medical Device Regulation SOR/98-282 as well as, Supplier Quality and the Safety Department.

corporate director of quality
manufacturing techniques, inc. (mteq)
Oversee the Corporate Quality Program including Quality Engineering, the Quality Management System based on AS9100C, Supplier Quality and the Safety Department.

quality engineering manager
manufacturing techniques, inc. (mteq)
Serve as MTEQ’s principle quality representative to customer quality organizations - Support MTEQ’s Electronic Fabrication and Production of PCB Assemblies and other complex electronic and communication products -Responsible to initiate and oversee root cause analysis, corrective & preventive actions, and process validations for resolutions to electronics “box and cable” manufacturing issues including processes, tools and equipment, and supplier quality issues. -Regularly report to senior management on quality data metrics and status of complex issues and coordinating resolution

senior quality engineer iv
drs technologies, inc.

lead quality engineer
aries group assigned to gentex
* Ensure that my assigned location is in Compliance with Corporate QMS, ISO9100 and AS9100 * Develop Quality Assurance Plan for all new products under development * Develop the quality and reliability requirements for all incoming , in-process and finished products * Design Process Flow Charts and Inspection Points for new production. * Responsible for the developed and management of quality and process improvement programs * Manage the supply chain of part and material and conduct quality audits on key suppliers. * Insure that all new documents and Drawings are developed in accordance with the QMS in place * Responsible to ensure that all incoming/outgoing material have meet the required quality level * Lead the implementation and coordination of correct of (CAPA) internally and/or on Suppliers. * Perform internal audit activities as per the requirements of the Quality Systems in place. * Address, resolve and bring all quality related issues to closure on timely manner.

quality manager
twidc test & consulting

senior member of technical staff
tellabs

component and test engineer
pulsecom
* Lead the component selection efforts and assist in quality and yield improvement * Responsible for the design, building and maintenance of test fixtures and software for qualifications and evaluations of components and sub-assemblies for high volume PCB production. * Conduct suppliers audit and provide recommendations that lead to improvement of Quality Systems. * Prepared failure analysis report on defected electronic components and assemblies. * Performed reliability studies of new process, material and components to generate adequate report

product development engineer
cherry semiconductor corporation
* Complete product development of mix-signal integrated circuits (Bipolar and BiCmos). * Generate test specifications, test time reduction, analysis of low yield lot. Perform Qualification and generate documentation to support Design Engineering with automated test characterization data. * Assistance in the Implementation of the ISO-9000 Program.

director of quality
theragen
Education
johnson & wales university
alix oe's Contact Information
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