Dong Lu

Phone: 609-***-****

E-mail: ac25y3@r.postjobfree.com

Princeton, NJ

CAREER SUMMARY

To apply my knowledge and expertise in quality and industrial field.

QUALIFICATION:

• Work experience in ISO 13485, ISO 9001 and TS 16949 registered manufacturing and clean room environments. Knowledge of cGMP 21 CFR Part 820 Quality System and work experience in medical and pharmaceutical industries. Clean room environment experience.

• Experience in quality fields including quality management system maintenance and improvement according to quality standard and regulation requirements. Worked on continuous quality improvement through six sigma DMAIC and SAP program. Experience of communicating with quality auditor and successfully passing third party auditing for quality standard re-certification.

• Coordination of internal quality auditing/survey, inventory maintenance, quality complaint investigation, root-cause analysis, corrective action and preventive action (CAPA) implementation through Non-conformance reporting (NCR), geometric dimension and tolerance (GD&T), blue print, statistical quality control (SQC) techniques such as cause-and-effect diagrams, scatter diagram for correlation, control plan, Pareto chart.

• Work experience in quality improvement through statistical analysis. Work experience on in-process monitoring, analyzing and improving product quality and process capability (Cpk) through statistical process control (SPC) and trends analysis. In-process analysis of product quality and processing trend through control chart. Successful application of statistical analysis (scatter diagram) on root cause analysis of non-conforming product investigation with successful product quality improvement.

• Experience in product quality inspection, sampling and characterization metrology equipment evaluation, selection, qualification, monitor, maintenance, calibration through Measurement System Analysis (MSA), Gage repeatability and reproducibility (R&R), metrology SPC and control chart. Evaluated measurement system variation and improved measurement capability through statistical analysis.

• Evaluation and qualification of technical specification for source materials from different supply vendors. Coordination of supplier corrective action request (SCAR).

• Experience of writing and updating standard operating procedure (SOP) and quality plans to maintain and improve quality management system. Work experience on assisting quality management review and quality metrics data collection and analysis. Application of internal assessment, audit and modification of company’s quality documentation system to ensure compliance with established quality procedure.

• Work experience of supervising /training technical staff, writing standard operating procedures (SOP) and work instruction on metrology equipment operation and calibration.

• Successful experience on initialization, design and management of new product development project to improve product efficiency. Optimization of materials processing through design of experiment (DOE).

• Commitment to partnering with design, R&D, manufacturing team, supporting staff, customers, suppliers and contribution to quality improvement.

• Proficiency in MS Word, Outlook, Excel, PowerPoint.

PROFESSIONAL ACHIEVEMENT:

Quality Assurance

Oct, 2016-Aug, 2017, Quality Associate in Medical and Pharmaceutical Application, Genpact Limited.

• Work on maintenance of global Product Quality Compliant system.

• Work on quality assurance management system maintenance to ensure adherence to cGMP, GDP guidelines and regulation.

• Work experience on quality control and review of data and reports of non-conformance product in global Product Quality Compliant system.

• Work experience on responding to customer’s complains on non-conformance product.

Quality Consulting

Nov, 2013-Jan, 2016, Consultant, Applied Quality Consulting, LLC, Princeton, NJ.

• Consultation on quality control and quality assurance.

• Consultation on statistical analysis for nonconformance investigation and correction.

• Consultation maintaining and improving quality assurance management system.

• Consultation on statistical quality control technology on continuous product quality improvement.

Quality Assurance

Nov, 2014-Feb., 2015, Contract Quality Engineer, Zimmer, Parsippany, NJ.

• Worked on quality system and production evaluation analysis.

• Analyzed measurement system and worked on calibration of quality evaluation equipments.

• Worked on measurement system analysis and calibration.

Quality Control, Product Development and Characterization

July, 2010-Feb., 2013, Engineer, Veeco TurboDisc Operations, Somerset, NJ.

• Worked on new test instruments qualification and validation through statistical analysis including Gage R&R. Applied statistical analysis for the root cause of measurement system variation.

• Applied structural, optical and electrical test equipment for characterization of advanced materials produced through metal organic chemical vapor deposition (MOCVD).

• Applied continuous monitoring and improvement of quality and process capability through statistical process control (SPC).

Quality Control and Assurance

Jan., 2009- May, 2009, Technical Staff, Eshopic, Piscataway, NJ.

• Analyzed customer's complaints for nonconforming products. Issued return merchandise authorization (RMA) to customers for confirmed product complain.

• Applied incoming products and final products inspection. Coordinated suppliers and engineering group for products quality improvement.

Quality Assurance and Product Inspection,

Feb., 2008- Jan., 2009, Engineer, Star Micronics America, Inc., Edison, NJ.

• Communicated directly with customers and took responsibility of complaint investigation. Lead and coordinated nonconforming reports (NCR’s), root cause analysis for nonconformance products, corrective actions and preventive actions (CAPA’s) implementation.

• Successfully improved and maintained quality management system. Applied advanced product quality planning (APQP), production part approval process (PPAP) and control plan for product design, development and manufacturing.

• Represented quality team and talked with third party auditing. Passed auditing for ISO/TS16949 re-certification.

• Applied internal quality auditing and modified company’s quality documentation system

• Applied auditing of vendor’s quality system and coordinated supplier corrective action request (SCAR) to satisfy quality standard and customer’s satisfaction.

Electrical Technology and Inspection,

Jan., 2007- Jun., 2007, Technical Staff, One Call Electrical Service Inc., South Plainfield, NJ.

• Applied electrical technology and inspection according to NEC standard.

Quality Control, Product Development and Inspection,

Apr., 1998- Apr., 2006, Engineer, Emcore Corp./Veeco TurboDisc Operations, Somerset, NJ.

• Successfully lead and managed project for high efficiency optoelectronic product development.

• Continuously improved electronic thin film products quality and process capability through six sigma DMAIC principal. Successfully applied statistical process control (SPC) for in process quality control.

• Developed, qualified and validated specification for source substrate materials from different supply vendors.

• Evaluated and validated test methods and analytical equipment. Validated advanced structural characterization technique as product evaluation method and transferred this test method to manufacturing.

• Managed and planned preventive maintenance (PM) and calibration for equipment. Coordinated instruments vendors for the maintenance and repairs of equipment.

• Performed job duty as shift supervisor, wrote standard operating procedures (SOPs) and work instructions. Trained new technical staff in the lab.

EDUCATION:

• Master, Materials Science and Engineering, Lehigh University, Bethlehem, PA.

• Bachelor, Materials and Metallurgy, Xian Highway Institute, China.

CERTIFICATION:

• Six Sigma Black Belt and Total Quality Applications Training Certification.

• Occupational Safety and Health Administration (OSHA) Certification.

SELECTED PUBLICATIONS:

D. Lu, D.I. Florescu, D.S. Lee, V. Merai, J.C. Ramer, A. Parekh, and E.A. Armour, Sapphire substrate misorientation effects on GaN nucleation layer properties. Journal of Crystal Growth, 272(1-4):353-359 (December 10, 2004).

D. Lu, D. I. Florescu, D. S. Lee, J. C. Ramer, A. Parekh, V. Merai, S. Li, J. J. Gardner, M. J. Begarney, E. A. Armour, Advanced characterization techniques of nonuniform indium distribution within InGaN/GaN heterostructures grown by MOCVD, physica status solidi (a), Volume 202, Issue 5, Date: April 2005, Pages: 795-798

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