An employment position as a Sr. Level Medical Quality Engr. for an organization with emphasis on cost reduction, while improving the overall customer satisfaction as well Quality of product line manufactured within forecasted budget.
I have over 25+ years of Quality Engr. from support of Design team in all aspect of design requirements to meet company (as well as FDA requirements) to Line support of product both at supplier level as well internal manufacturing in all aspect of Mfg. operations. With over 10 years of background in FDA environment (MyronL, Accumetrics, Alaris, HearthScan, LifeScan, Siemens Medical, etc..).
My expertise in high Tech firms with in all aspect of Quality Engr. with R&D as well as being a liaison between Manufacturing & end-user. Using tools such as Taguchi & PPAP and process validation tools such as MiniTab, APQP & PFMEA, and Quality tools such as 6 Sigma, SPC, LEAN and implementation of 21cfr820, ISO13485, IPC (600, 610E, 615). Over the years, I have developed special skills that would allow me to work with internal customers as well as managing External customers such as vendors and audit agencies to ensure compliance to company STD as well FDA compliance (in generating CaPA report and V&V validation process) to work different programs simultaneously to meet targeted deadlines.
SPC, MiniTab, ISO, 6-Sigma, Lean Mfg, Supplier quality, Internal & External Audit, CaPA & Customer & FDA audit support
Knowledge of IPC, ISO9000 & 13485, FDA 21cfr820, GMP specifications, requirements & implementation
Vendor survey, and sub-contract management, Customer & Engr. support from design through product life.
Identify& develop new quality metrics as needs rises for R&R gage study and Process Quality report to Mgt.
Knowledge of product inspection, lot sampling plans & tool calibration Program
Product realization (MFG) and supply chain related process in accordance to APQP & PPAP
Skill in FMEA and low level trouble shooting of ElectroMech. Assy. for CaPA investigation & 8D report to customer
Experience in Developing, Implementing/leading an effective MRB program
Experience to lead an effective continuous Improvement LEAN (Kaizen ), 5S program related to both product & process
Expertise in SMT, PTH, Test, Micro BGA, OSP, Kevlar, Roger, Lead free, RF Mfg.
Expertise in forming, component insertion & placements, wave & reflow soldering, cleaning process, screen printing
ISQ, Inc. San Diego, CA 1/06 – Present
Working with clients (both short & long term) in their quality & product transfer through iSQi with the following sample of past & current Clients such as:
SKF, Signal monitoring OEM ISO9000 San Diego, CA
Sr. Program Quality Engr.
Working as both Quality Engineer and inspector (in both Rec/Ship as well as in process Insp.). A hands-on type of working environment, I focus on all aspect of supporting Mfg. Quality Req. inspecting incoming material and out of box audit on finish goods prior to shipment, as well as spot checking of work in process throughout different Mfg. line productions.
Processing any none conforming Material through NCMR & MRB process to resolve deficiencies found.
Working with R&D Engr. in rectifying new product under development to ensure they will meet certification agency & customer expectations as well as meeting companies over all quality requirements.
Work with suppliers in deficiencies found so they can take corrective action and rectify deficiencies before the overall quality of product jeopardized.
Myron L, OEM Both FDA & Commercial Solution Quality systems Carlsbad, CA
Working in Quality Mgt. Capacity, I work with 6 Insp. (both R/I & InProInsp)
Not only managed inspectors, but also worked with them in showing them faster and more accurate way of inspecting parts as well as providing guidelines on how to read and tabulate Quality STD to meet certification and customer expectations.
Worked collaboratively with R&D in quality related issues for new product development.
Work with suppliers (both Domestically & Internationally) in improving overall quality product Mfg. by them.
Was the champion in Lean activities and MRB/NCMR process.
Represented Co’s quality in developing CAPA projects to satisfy customer’s expectations.
Set up quality & Dept. procedures in accordance with GMP to meet FDA Req.
Marway Power, OEM AS-9100/ISO9000 Irvine, CA
Technology Transfer / Quality Engr
Although I was brought on board to work with R&D in developing a new product that can be produced effectively in Asia
Worked to support customers (defence Contractors) such as Boeing, LockheedMartin, BAE, etc. in all aspect of their quality Requirements from ECO release implementation to 8D report. Working with other Dept. in AS9100 (Rev.C implementation).
General Atomics, Elec Div. OEM AS9100 San Diego, CA
Sr. Program Quality Engr.
Main area of responsibility was to support all aspect of program quality for Aircraft Launch and Recover program (EMAL&RS), RayGun, Predator, Capacitor & power supply Project for Mil-Applications & Fuel (liquid) metering program (for Asian market).
Managed all aspect of main program (EMAL&RS) from reading proposal for quality Req. for the EMS Div.,
Implementing over 3000 ECOs, working with supplier in quality Req. to in process quality detection and rectification of any deficiencies found.
Developing charts and tracking systems used by Mgt. in different div. to track ECO implementation progress on daily basis.
Accumetrics FDA-OEM San Diego, CA
Quality / Mfg Engr.
Direct assignment was to ID local suppliers and work with them to establish quality Req. which meet and/or Exceed FDA requirements.
Survey and qualify suppliers, and monitor their Mfg./shipment quality progress to Mgt. as well as develop a ramp up program which would not jeopardize quality as volume increase drastically.
Manage all None conforming (FDA monitored) deficiencies (via CaPA report) on weekly basis (over 1000 monthly) and report finding to QMR quarterly.
Irvin Aerospace AS9100 Santa Ana, CA
Sr. Program Qualify Engr.
Worked on newly awarded NASA project (man mission to mars) to tabulate contract quality Requirements, report and data expectation for customer, develop suppliers as well as internal quality Req. for Parachute & airbag for Mission module for both Mars landing as well as return back to earth water landing requirements.
Developing matric of customer quality report requirements for design quality phase, testing, to out of box audit prior to shipping to NASA which should have lasted over 4 years of data collection and testing in cooperation with suppliers as well as internal Mfg. quality…
Maxwell AS9100 San Diego, CA
Improve internal quality / Yield from 95% FPY to over 99.995%FPY, reduce waste & time to STK from R/I, as well as supplier quality (worldwide)
Ensure the company would go from ISO9000 certification to AS9100 (companywide).
Managed over 15 inspectors in both RI & Ship and In process Inspection.
Introduced AOI & data collection/Tabulation to generate Mgt. quality reporting on weekly basis.
Achieved 89% audit score for AS9100 (higher than Boeing who establish AS9100 initially), taken internal trip to supplier in Asia as well work with them to improve quality product Mfg. there as we as reduce cost by eliminating waste locally.
Reduce Incoming inspection time from 1 week in RI to less than 4 Hrs before martial was approved for production.
Somfy, 7/04 – 12/05 Poway, CA
Quality Engr. / Mgr.
Hired as quality Engr. and promoted to Quality Mgr.
I was in charge of all aspect of design certification and qualification, supplier quality and corporate quality from statistical Methods to program quality, 8D report back to corporate on deficiencies detected.
Comarco, 1/03 – 5/04 Lake Forest, CA
Supplier Quality Engr.
Responsible for all aspect of supplier quality working with over 50 suppliers in 11 different countries in Pacific Rim from supplier selection, qualification, ISO audit program, and supplier quality Mgt. Statistical Methods, working with design Engr. to make sure product are producible with quality requirements that could be met.
Established a better supplier quality (mainly in Asia & SD base) via CAPA process and 8D reporting system
Comtel, 1/00 – 11/02 Tustin, CA
Engr. Supervisor (MFG, Test, Quality)
Manage over 25 Engr. in MGF/Test/Quality Engr. ISO certification and audit, work with over 30 customers (both FDA and commercial Electronics) in new product releases (over 100 each) throughout the MFG/Ops as well as quality requirements and customer audit.
Established a better supplier quality via CAPA process and 8D reporting system.
MSL, 97 – 99 Valencia, Spain
Engr. Mgr. (MFG, Test, Quality)
Assigned for 2 years program in Spain, Manage over 75 Engr. in MGF/Test/Quality Engr. ISO certification and audit, work with over 20 major customers in Europe (both FDA and commercial Electronics) in new product releases (over 50 each) throughout the MFG/Ops as well as quality requirements and customer audit.
Corporate reporting on all aspect of Operations.
Established quality system via CAPA process and 8D reporting system to meet customer requirements.
Lambda, 94 – 97 San Diego, CA
Adv. MFG Engr Mgr.& Tech. Transfer
Work with two corporate design centres (SD &NY) in charge or launching product to all manufacturing locations (worldwide).
Manage 6 Mfg, Ind. QA Engr. (3 at each location) in creating a smooth transition between design and operations.
In setting up line process, procedures and equipment for smooth transition from R&D into volume production.
Technetics, 90 – 94 El Cajon, CA
SMT MFG Engr. & National Sales
Responsible for Mfg. Engr. / SMT Line support and other Mfg/Operation requirements, from capital equipment selection & justification to creating SOP and operator training.
Also promoting the contract Mfg. aspect of the company to potential clients (both FDA and commercial Electronics). LEAN projects.
Vernitron, 88 – 90 San Diego, CA
Chief Industrial Engr.
As Chief Industrial Engr. was responsible for all time and motion study, time STD, traveller/router setup factory layout and relocation. 5S activities in a continuous improvement projects.
Cipher, 85 – 88 San Diego, CA
Sr. Mfg. Engr.
As an SMT Mfr. Engr., responsible for capital equipment justification & procurement, SOP, operator training, direct line support, sustaining Engr. and new product (NPI) releases into Ops. Kizan, 5S activities in process improvement projects.
Burroughs, 80 – 85 Mission Viejo, CA
As Industrial Engr. was responsible for plant layout, P&P and Manual Mfg. Requirements of factory, time and motion study. Continuous Improvement projects.
Honours & Achievements
Cipher : Personal award for cost reduction of over $250K
Burroughs : Spotlight person of the month for cost reduction of $100K
A.S.M.E. : First place design winner, for design of a future jet fighter
C.S.A. : Chairman safety committee
A.I.A.A. : Vice President, South-eastern Conference
B.S. in Mechanical Engineering; University of Mississippi (1980)
MBA-Technology Mgt., University of Phoenix (in progress)
- Statistical Process Control (SPC) - TQM, 6 Sigma
- PPAP & APQP, R&R gage study - PFMEA & 8D/CAPA reporting
- Taguchi Method, HALT&HASS - Quality Planning & Evaluation, V&V
- Lean Mfg., Cost Reduction - Effective Presentation Skill
References and portfolio will be furnished upon request.