Quality Engineer

SUPRAVAN KHONGKRUAPHAN (CQE)

*** **** **** ****** * Eugene, OR 97401

Tel :774-***-****

Email:

abm5xc@r.postjobfree.com

OBJECTIVE An opportunity to obtain a Quality Engineer or Product Integrity

Manager position that utilizes my experience in the consumer product

and medical device industry.

M.S. Plastics Engineering, University of Massachusetts Lowell, MA

EDUCATION / (Dec. 05)

CERTIFICATION B.S. Chemical Science, Silpakorn University, Thailand (May 01)

Certified Quality Engineer (Dec. 09)

Certified J-STD-001 Soldering (Jun. 07 )

PROFESSIONAL EXPERIENCE

Product Integrity Manager, Learning Curve Brands Inc. Stoughton, MA

Developed and implemented quality and safety standards and operating

procedures for consumer products / medical devices.

Ensured the overall quality of the final product met or exceeded

customer and federal regulations.

Provide necessary safety warnings and review all packaging for claim

substantiation.

Reviewed all CPSC / Customer / Consumer complaint and investigation

report.

Interacted with third party testing laboratories for product testing

Jan. 08 and analyzing the results.

- Audited manufacturing facilities in Far East Countries, to evaluate

Present their quality and management system and also managed Disney Code of

Conduct/Factory audits.

Serve as point person on all Product Integrity communication with

the Far East Product Integrity team.

Met with consumer care team weekly and analyzed feedback received

from consumer returns and provided technical assistance to Consumer

Care as needed.

Reduced defected consumer call by 50% within 6 months period.

Medical Device

Performed an office leader for ISO 13485 audit, and internal lead

auditor.

Implemented and managed the Quality System Manual to satisfy the

requirements of ISO 13485 and 21 CFR 820 Quality System Regulation.

Ensure product's compliance with FDA (i.e. 510(k) Premarket

Notification Process), CE, UL, GMP and ISO 13485 requirements.

Managed FDA registrations and device listing for entire medical

devices both US and Canada.

Quality Engineer, Advanced Interconnect Inc.,Franklin, MA

Created quality specification of manufactured parts as delineated

drawings.

Build and maintenance the test harness; perform quality testing.

Investigated customer complaints, root cause analysis, and evaluated

Nov. 05 and issued corrective action.

- Assured product integrity and quality, and satisfaction of customer

Jan. 08 requirements.

Exposure to Statistical Process Control (SPC) / Six Sigma / FMEA /

8D / DOE.

Running the Material Review Board meeting, for quality material

disposition.

Performed ISO 9001-2000 Internal Auditor and manage Qualification

/Certification Program (UL, CSA, and ISO).

Wrote work instruction and procedures in accordance with ISO 9001

Standard.

Associate Quality Manager, King Pac Industrial Co., Ltd., Thailand

July 04 Trained in the blown film extrusion process with extensive emphasis

- on zip lock bags, conducted process analysis and quality control on

Sep. 04 products.

Consulted for the new product specifications for Product Development

Group.

Quality Control Technician, Advanced Cable Ties Inc., Gardner, MA

May 03 Responsible for in-process inspection and testing, to ensure that

- the molded parts meet quality requirement.

Jun. 04 Team member for International Standards Organization development

Worked on a team to increase the first-pass yield of material,

resulting in less defects and greater machine up- time.

Laboratory Staff, Thai Food International Co., Ltd., Thailand

Managing laboratory operations and developing analytical method

Jun. 01 using method validation concepts in accordance with ISO 9001 and ISO

- 17025.

Jan. 02 Maintaining troubleshooting and also support installation,

calibration, and operation of analytical instrument such as AAS,

UV/VIS Spectrophotometer, pH meter, Bio-Sensor.

Maintaining product's compliance with FDA, GMP and ISO Standard.

"Effect of Plug Design on Thermoforming Polypropylene Parts"

PROJECTS Determined the effect of plug design (shape, size, depth, and

temperature) on thickness distribution, mechanical properties of

M.S. THESIS thermoformed polypropylene parts.

Compared the experimental results to T-SIM computer simulation.

"Effectiveness of Activated Charcoal in Removed Heavy Metal from

PROJECTS Waste Water"

Removed heavy metals from waste water by using activated charcoal

B.S. THESIS Analyzed amount of heavy metal in charcoal by using AAS, and scanned

pattern of heavy metal on activated charcoal by using SEM.

Risk Management and Analysis for Medical Devices Certificate (May 09

)

CE Marking - EU Directives, and Guidance Documents Certificate (Dec.

08 )

TRAINING Internal Audit ISO 9001-2000 Certificate (Jun. 06 )

ISO 17025 for Laboratory and Internal Auditor for ISO 9001:2000

(Nov. 01 )

IPC/WHMA-A-620 and 610 (Feb. 06)

Roll-Fed Thermoform Tooling, Machine, and Material (Sep. 05)

Design of Food Packaging (Materials, Processes, Assemblies) (Jan. 05

)

Conducted a DMAIC study for a rubber compounding and manufacturing

facility as part of a Six-Sigma Green-Belt project (Dec. 05 )

SOFTWARE Mold flow, T-SIM, Solid Works, Minitab, AutoCAD, and Microsoft

Office.

PUBLICATION / S.Khongkruaphan, J.Mead, S.Orroth, "Effect of Plug Design on

SPEAKER Thermoformed Polypropylene Parts", Annual Technical Conference, SPE,

May 2006.

MEMBERSHIP American Society for Quality (ASQ)

American Society for Testing and Materials (ASTM) F-15 sub committee

Society of Plastics Engineers (SPE)

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