Objective:
Seeking a challenging position of Process Quality Engineer .
Knowledge, Skills, and Abilities:
• Abilities to understand, provide, support and perform Technology Transfer,
Quality Assurance and Quality Control in medical devices environment.
• Abilities to work on Quality Engineer, Lean, Six-Sigma, Quality Systems, Validation, Change Control, Manufacturing, SPC, and CAPA.
• Knowledge of work and analyze on Risk Management.
• Knowledge of work on electrochemical, plating, edging, printing and coating.
• Knowledge of design techniques, tools, and principles involved in production
of precision technical plans, blueprints, drawings, fabrication, assembly and installation, and medical device models.
Experience:
04/00-04/12
Chemical Engineer
H.R. Simon and Company, Inc., Baltimore, MD (410) 636-5555/(410) 941-9405
Process Quality Engineer, Chemical and System Engineer
* Maintained the GC and HPLC systems and helped develop new methods on HPLC and GC. Performed QC/QA (Quality Control/ Quality Assurance) final products. Performed all aspects of the laboratory operations in compliance with GLPs and cGMPs.
* Worked with polymer, organic, inorganic, solvents, powders, epoxy, and toxic chemistries for consumer graphic arts, medical imaging solutions, and medical devices. Designed and formulated sealants & luting cements, restorative adhesives, tray adhesives, epoxy glue agents, and photochemical solutions.
* Improved upon traditional analytical methodologies and developed new non–hazardous materials. Established in-process inspection program of intermediate and finished products. Investigated defected products to determine the root cause and then took preventive measures.
Mechanical Engineer
* Provided technical support to staffs and troubleshooted processes in a production facility to maintain continuous operational efficiency. Worked closely with equipment operators to get feedback on the operations of each process to prevent shutdown.
* Led Research and Development of specific equipments for manufacturing processes such as machine coolant controls systems that includes: nozzles, sprinklers, air pressures, fluid mixers, float level, fill gauges, thermo-sensors, and Pneumatic actuators.
* Adopted advance mechanical and automation technologies to reduce manufacturing costs and improve operational efficiency.
* Researched and designed various CCD/CMOS sensors for digital x-ray detectors, medical imagers with companion software for highest resolution of image display. Developed new techniques to work with low dose x-ray machines. Designed and developed hardware and software to speed up image processing that is compatible with Digital Imaging and Communications in Medicine (DICOM).
* Demonstrated success and experience with international standard (ANSI/ISO Q9001: 2000, 13485:2003), Lean Six Sigma in Quality Assurance System, and FDA-510K, and IEC 60601-1.
05/99-10/99
Trans-Tech: a subsidiary of Alpha Industry, Adamstown, MD (301) 874-6523
Ceramic Powder Technician
* Inspected and tested products – Ceramic composites materials include: Coaxial, Dielectric, Dielectric Resonators, and Coaxial Resonators
* Performed quality test on raw materials and mixed, blended, filled in trays and extruded powders. Researched and analyzed new products.
04/98-10/98
LZR Electronics, Inc., Gaithersburg, MD (301) 921-4600
Quality Control Assistant
* Tested circuit boards
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