Engineer Quality

Anthony Kim C Yuen

*** *. *** ***. ******, MA ***70

Home phone: (617) 471- 9839

Mobile phone: (617) 966 - 6321

Email: ********@***.***

Summary of Qualifications

Highly motivated and results-oriented quality assurance engineer with ASQ

Certified Quality Auditor certification and Six Sigma Green Belt

training. Knowledge of ISO 13485:2003, ISO 9001:2000, ISO 14971:2007, ISO

14001, MDD, AIMD, AS9100, EU Council Directive 93/42/EEC, 21 CFR Part

820, 21 CFR Part 210 and Part 211. Solid track record of consistently

meeting and exceeding company goals and objectives.

Professional Work History

Product Analyst II/ Complaint Management Specialist (Contract

position)

Boston Scientific Corporation, Marlborough, MA

Jun. 2008 to Dec. 2009

( Perform systematic review and closure of more than 1,000 complaint

files.

( Draft more than 500 initial and supplemental FDA MedWatch reports

within mandated timelines.

( Draft 300 CeSub MedWatch reports for Phase 1, Phase 2 and Phase

3 of remediation projects.

( Perform follow up with customers, sales representatives and

international territory managers regarding complaints.

( Provide technical guidance and training to new Product

Analysts.

( Ensure complaint records, MedWatch reports, and applicable complaint

handling documents are compliance with

Good Documentation Practices (GDP), ISO 13485:2003, local and

corporate work instructions.

Quality Assurance Engineer (Contract position)

Analogic, Peabody, MA

Jan. 2008 to Apr. 2008

( Performed internal audit, Design History Files audits, ESD and

calibration assessment.

( Performed follow-up audits to ensure corrective and preventive

actions were effectively implemented.

( Provided support for three TUV audits.

Quality Engineer/5S Operation Supervisor

Teleflex Medical (Formerly known as Arrow International), Inc.,

Everett, MA Jan. 2006 to Dec. 2007

( Performed closure of 200 complaint files for a corporate

remediation/backlog project within mandated timelines.

( Performed root cause analysis of customer complaints with R &D,

manufacturing and process engineers.

( Used Six Sigma tools to monitor and support CAPA projects.

( Conducted in-house training for production and quality team

members.

( Requested raw materials from warehouse to meet scheduled

production.

( Assisted in completing the Corporate Operational Excellence

Project successfully.

( Planned, coordinated and completed 5S continuous improvement projects

relating to plant safety, productivity, scrap

reduction and quality improvements, and also responsible for

metric reporting.

( Conducted quality assessment in accordance with FDA, QS regulations,

ISO 9001 and ISO 13485:2003 requirements.

( Provided assistance to RA/QA regarding reviewing responses

which are related to FDA inspection.

( Monitored SCAR activities and resolved quality issues with

suppliers domestically and internationally.

( Reviewed and approved quality plans for Incoming Inspection to

follow on purchased components.

Quality Engineer (Contract position)

Columbia Tech, Worcester, MA

Sep. 2005 to Jan. 2006

( Performed root cause analysis and implement corrective and

preventive action for customer complaints.

( Analyzed complaint data for external customers.

( Worked with suppliers and customers to resolve critical

quality issues successfully.

( Provided QC/QA support to the contract manufacturing operation.

( Provided support for the implementation of ISO 13485:2003.

( Worked with project managers, manufacturing and testing engineers to

resolve customer & suppler quality issues.

( Interfaced with Document Control and Manufacturing on documentation

issues.

( Performed audits of the QA system, reviewed and approved ECO, and

updated quality records as needed.

Supplier Quality Engineer

Karl Storz Endovision, Charlton, MA

Mar. 2005 to Aug. 2005

( Participated in supplier audits and support cost reduction

effort.

( Planned, organized, evaluated and reported supplier performance to

provide key performance information to

the Director of Quality, Director of Materials and Six Sigma Corporate

Leader.

( Lead the supplier qualification effort and maintained supplier

corrective action request logs.

( Reviewed NMR trends and worked with MRB to resolve issues that

involve both company and suppliers.

( Worked with QA and Materials to streamline/improve

receiving/receiving inspection areas.

Quality Engineer /Supervisor

Keurig, Inc., Wakefield, MA

Oct. 2003 to Jan. 2005

( Performed qualification of a critical part that reduced the material

cost from $300,000 to $150,000 annually.

( Supervised inspectors and brew system testing operators on daily

activities.

( Provided QA/QC support and visited contract manufacturers and

suppliers internationally and domestically to

ensure compliance with quality and customer requirements.

( Performed audits of new and existing suppliers and contract

manufacturing operations in China and Canada.

( Performed systematic review and root cause analysis of customer

complaints in a time manner.

( Evaluated and audited plastic part, mechanical part, and

electronic components suppliers to assure consistently

high incoming material quality.

( Assured high level of brew system quality through design

validation, life testing, and ongoing audits.

( Support ongoing quality system development and optimization &

perform FMEA of new products.

( Maintained and optimized quality reporting systems, metrics,

trending, and reporting.

( Monitored the calibration system and review, reviewed and

approved engineering change order (ECO).

Quality Engineer /Quality Supervisor (Contract position)

StatSpin, Inc. Norwood, MA

Mar. 2003 to Jun. 2003

( Performed process and equipment validation for Lipemia clearing

reagent and thermocouples.

( Performed quality support for Lipemia clearing reagent

manufacturing.

( Support the execution of quality plans, process control plans

and DFMEA.

( Supervised labeling, incoming and packaging operations.

( Reviewed, printed and updated all in-house printed labels.

( Participated in new product development of LipoClear Reagent

activities, review risk assessment report and analysis.

( Worked with purchasing to monitor and upgrade vendor

performance.

( Performed periodic audits of the QA system and audit supplier quality

systems, and qualify products per the

validation plan.

( Performed final QA review and release of production records.

( Performed reliability testing on new and existing products.

( Performed failure investigation for customer complaints, followed up

CAPA and RMA.

Quality Assurance Engineer (Contract position)

Mitek Products, ETHICON, Inc. a Johnson & Johnson company, Westwood, MA

Oct. 2002 - Feb. 2003

( Participated in the weekly MRB meeting for the disposition of non-

conforming issues related to medical devices.

( Worked with Mitek evaluators to resolve customer complaints and

implement corrective and preventive action.

( Worked with suppliers to resolve material issues related to inspection

discrepancy reports.

( Participated in the monthly supplier scoreboard meeting for the review

of quality data for supplier performance.

Validation Engineer (Contract position)

Acambis Inc., Canton, MA

Aug. 2002 - Oct. 2002

( Maintained the validation schedule of smallpox vaccination projects

for U.S. Government.

( Maintained validation files.

( Created, modified and edited forms & S.O.P. for the

computerized systems that comply with 21 CFR Part 11 requirements.

Quality Project Engineer (Contract position)

Baxter Healthcare Corp., Andover, MA

2001 - May 2002

( Reviewed batch records for drugs.

( Performed internal audit and follow-up audits for the company.

( Participated in a software protocol evaluation for the electronic

submission of drug information to FDA.

( Conducted quality assessment, coverage assessment, risk analysis, gap

analysis, mitigation & system action

planning for electronic records and electronic signature project.

( Developed system action plan to improve current computer information

system.

( Performed evaluation of new processes for conformance to GMP, DEA, ISO

and FDA regulation.

( Developed and perform protocols, validations, and evaluations

necessary to support Part 11 of the CFR as

it relate to the manufacturing floor and controlled substance

distribution operation.

( Developed specification and SOPs necessary to assure regulatory

compliance is maintained.

( Served as a project coordinator for the development and implementation

of electronic signature process validations.

( Worked with vendors to perform software evaluation in the areas of

training, labeling, documentation control,

and Corrective and Preventative Action for ERES compliance.

Quality Control Supervisor/Quality Assurance Engineer

Power-One HDBMP, Boston, MA

1997- 2001

( Worked with production planning groups and quality control to exceed

monthly production goals.

( Worked with RMA coordinator to resolve customer issues.

(. Ensured that corrective measures meet acceptable reliability

standards and that documentation is compliant with requirements.

( Provided short-range planning concerning staffing requirements,

overtime requirements, schedules, budget,

and space requirements for receiving inspection, process inspection

and first article inspection.

( Assisted in implementing 5S and changing the one of production

lines into lean manufacturing environment.

( Performed performance appraisals, disciplinary actions, job

descriptions, interviewing, rewards & recognition, and

training/development.

( Acted as logistics facilitator to ensure all elements of the

distribution process are coordinated in such a way that

customer requirements and time constraints are met.

( Worked with suppliers to resolve supply chain issues and

implement cost reduction initiatives.

( Support concurrent engineering efforts by participating in

design development projects representing Q.A.

( Participated in MRB to review supplier and production defects

and assure corrective and preventive

opportunities are identified and implemented.

Quality Control Coordinator

GE Infrastructure, Aviation (Clean Harbor Environmental), Lynn, MA

1996

( Performed the scheduling and monitoring of the training program for

employees.

( Performed document and record control.

Quality Associate

Hiram Walkers & Sons Inc. Braintree, MA

1995

( Developed reporting systems and procedures to support multi-channel

marketing.

( Researched and developed new strategies to analyze marketing data to

recommend new targeted mailings.

Education

M.S., Engineering Management (Major: Quality Control and Operation

Research), Northeastern University.

B.S., Industrial Engineering & Information System, Northeastern

University.

Professional Certificates & Affiliation:

ASQ Certified Quality Auditor (CQA), # 38741, Dec. 6, 2008

Certified Internal Quality Auditor for ISO 13485:2003, Mar. 2008 (Quality

Support Group).

Certified Internal Quality Systems Auditor for ISO 9001:1994 & ISO

9001:2000, Oct. 1999 & Dec. 2000 (Alamo).

Senior Member, ASQ, 2006

Computer Skills:

Trackwise, e-MDR, CRRH (CeSub) Electronic Submission Software, Siebel, SB

Client, FileMaker Pro 5.0, Microsoft Office 2007, Outlook & Project, MAX-

MRP, AS/400, Pilgrim, PDM, Agile, AutoCAD, SAP, Minitab 14, InfinityQS,

ApproveIt, PrisyMedica, Internet Explorer and Visio.

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