Engineer Quality

Frank Zhao

** ***** *****

Irvine, CA *****

Tel: 949-***-****

E-Mail: ***********@*****.***

OBJECTIVE: To obtain position as the "Sr. Quality Engineer, 42314BR" with

** ***** *********** *** **ality assurance experience in highly

regulated industries (Medical Devices, Aerospace & defense).

QULIFICATIONS

. ASQ CQE, ASQ CQA & ISO Auditor.

. Engineering background, 10+ years QE experience in highly regulated

industries that design and build of all aspects of Medical Devices,

Avionics LRUs, and MIL-Spec customized electromechanical systems, etc.

. A thorough understanding of US FDA QSR, ISO 13485 quality and regulatory

requirements and standards.

. Familiar with Complaint Management System, MDR, complaints and quality

metrics trending analysis.

. Hands-on problem solving skills in complaint & product/process

improvements through team based effects.

. Expert in QE tools of Statistics, Six Sigma, DOE, SPC, Control Charts,

FMEA and Risk Managements.

. Proficient in MS Office (Excel, Word), Complaint Master, ETQ, Project

Management software packages.

. Participated in supplier management; supplier audits, evaluations and

qualifications.

PROFESSIONAL EXPERIENCE

J. T. Posey MEDICAL, Arcadia, CA

1/2009 - Present

Sr. Quality Engineer

Responsible for planning, organizing projects to meet organization's

quality objectives and goals; Completing complaints and failure

investigations, root causes analysis; facilitate implementation of

corrective/preventive actions.

. Performed complaint investigations, complaint documentation reviews (DHR

files, complaint history, hazard analysis, etc). Coordinated with Product

Surveillance Group to evaluate for potentially reportable status,

completing MDR reports within regulatory timelines and improve the

complaint process.

. Conducted quality engineering aspects of activities and drive knowledge

based process and protocols in compliance with FDA Regulations GMP/QSRs,

ISO 13485.

. Established and maintained complaint, NCR and product performance data

metrics and interpretations for product performance based upon

statistical analysis (Trend charts, Pareto Analysis, etc) to identify

potential trends with FMEA (Failure Mode and Effect Analysis) and trigger

levels for the Corrective and Preventive Action (CAPA); tracked

improvements and effectiveness to assist in preparing data and analyses

for management decisions affecting quality operations.

. Created and installed quality process sampling systems, procedures,

capability studies for development processes and statistical techniques.

. Established and implemented inspection sampling plans per ANSI/ASQ

Z1.4/Z1.9 standards.

. Conducted evaluations, tests. Hands on participant in failure

investigations to determine root cause and potential patient risk,

identifying failure modes, frequency, and severity. Ensuring that

corrective action decisions and investigations are based on sound

engineering analysis and resoled with effective resolution.

. Liaison working with crosses functional groups, R&D, mfg and production;

responsible for multi-projects providing engineering support to the

design verification and validations of new products or quality & process

improvements.

. Supporting internal and external quality and compliance audits;

Interacted with suppliers on quality issues.

Thales Avionics Inc, Irvine, CA

3/2006 - 9/2008

Sr. Investigation Engineer

Provided the Boeing 787 Dreamliner Program In-Flight Systems PCU (Passenger

Control Unit) and SEB product lines technical & manufacturing support for

quality, process, reliability and performance (Hardware, Software, Boards

level and Systems level).

. Applied engineering and statistical principles to evaluate product

performance to improve the quality, safety, reliability and

maintainability of products and systems.

. Proficient in statistical analysis, SPC, lean mfg and six sigma and

interpretation; utilized in the troubleshooting, testing, qualification

and evaluation for products and processes.

. Conducted testing utilizing test protocols, root cause analysis and

failure investigation addressed workmanship, assembly methods, process,

Acceptance Test Protocol, HASS/ESS reliability tests and incoming or non-

conforming material issues, etc.

. Monitor production performance and status, implementation of advanced

quality practices: quality and performance trending, process capability

Cp, Cpk, Pareto analysis and Statistical Process Control (SPC).

. Applied knowledge of Advanced Product Quality Planning tools, Risk

Management, Failure Mode and Effect Analysis (FMEA) and Fault Tree

analysis to drive quality improvement.

. Identified and implemented improvements to manufacturing process, product

quality and cost based on evaluation of process and product performance

data.

. Performed hands-on troubleshooting; ATP test with manual bench / test

equipments to identify any issues, Board level/LRU level/System level

hardware defects and software corruption.

. Participated in the Failure Review Board (FRB), Corrective Action Reports

(CAR) and Supplier Corrective Action Requests (SCAR).

. Training of ISO AS9100, Six Sigma, and Lean Manufacturing.

Rapid conn Inc, Foothill Ranch, CA

4/2004-3/2006

Sr. Quality Engineer

Developed and implemented the quality systems for the local and offshore

manufacturing facility.

Interfaced with engineering, product development, operations, customer

service, and contract manufacturers (CM) to resolve issues captured during

production assemblies and final ATP test.

. Responsible for the deployment of the corrective and preventive action

plan, which addressed process, product or component failures alerts for

operations and implemented efficient solutions.

. Coordinated rejection/failure analysis both for production and field

returns.

. Analyzed and optimized component selection to reduce design and

manufacturing cost, increase of the production yield and environmental

compliance (RoHS).

. Provided feedback to design engineer to support technical proposals.

Managed all aspects of the projects, Data analysis, Specs, BOM, ECO, AVL,

offshore supplier's audits and qualifications.

Launching Tech Inc, San Jose, CA

9/1995 -4/2004

Sr. Manufacturing/Quality Engineer

Provided engineering support and project management skills toward product R

& D, testing, schedules and cost Hands-on experience in a fast-paced, Hi-

REL EEE components manufacturing facility for defense industry.

. Developed in-depth working knowledge of IPC Standards 610/620 and MIL-

SPEC/STD requirements.

. Perform first article built activities for robust MIL-SPEC RF Microwave

sub- systems for L3 Communications, Condor Systems and US ARMY.

. Developed, improved and validated the design, mfg and testing processes

for MIL-SPEC/STD assemblies.

. Initialed and managed ECR/ECO process; updated mfg Drawings, BOMs,

Schematics and Specs.

. Supported projects by contributing to the development of project quality,

schedules, status, budget, costs.

EDUCATION & CERTIFICATIONS

ASQ Certified Quality Engineer, ASQ Certified Quality Auditor, ISO 13485-

2003 Auditor

B.S., Civil and Mechanical Engineering, TsingHua University

Computer Electronics Technology, Mission College

TECHNICAL SKILLS

Platforms: Windows, Linux

Applications: MS Office, Outlook, Agile, AutoCAD, MRP/M2K/ROI, ETQ &

Complaint Master

CITIZENSHIP

U.S. Citizen[pic]

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