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Engineer Quality

Braintree, MA, 02184
October 25, 2018

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Zhixuan An

*** **** ***** ***, **** ***, BRAINTREE MA 02184 • 617-***-**** • ENGINEERING PROFESSIONAL

A manufacturing professional with over 4 years’ experience of Manufacturing Engineering and Quality Engineering in medical device and pharmaceutical instrument companies. Continuously improvement on product quality process with strong root-cause troubleshooting skills. Quality Control analysis and evaluation. Provide components quality reports, SAP quality notification crate and on-site quality issue solving for customer. Decent understanding on product components CAD drawing and PCB schematics reading. Cleanroom experience. Seeking a quality assurance or quality control engineer position that can expand my experience and advance my skills. Key Skills

Six Sigma Green Belt-Trained AutoCAD products

Root-cause troubleshooting Product Quality Database Application ISO 9001 and 6S Standards Quality Issue Solving for Field Engineers QC Corrective/Preventive Action Manufacturing Tools IQ, OQ, PQ Business Process Mapping Cleanroom experience

PCB Schematic understanding First Article product testing Solidworks Manufacturing

Microsoft Office Suites Inspection of Pharmaceutical Instruments Quality Management System CAPA


Quality Engineer at Malvern Panalytical, Ltd., Northampton, MA Aug 2016 – Present

Drove the non-conforming material process and root cause investigation through coordination with production engineer and manufacturing team

Assisted Quality Engineering management and Product Engineering managers to implement and develop process and product improvements

Assisted the Quality manager in establishing, implementing, and maintaining the quality management system

Had an active role in the development of 6S manufacturing and lean manufacturing

Worked with manufacturing engineers and product managers to create, revise, and review BOMS and work instructions

Drove supplier performance improvement through root cause analysis, corrective actions, and supplier performance reviews

Utilized manufacturing quality tools, such as IQ, OQ, PQ, control plans, process verification plans, and process data analysis with the ISO 9001 Standard

Utilized SPC data to identify out-of-control conditions and assist in calculating suppliers’ capabilities

Experienced with SAP quality notifications, managed process deviations, participated in the daily product process and the material review board meeting

Manufacturing Engineer Intern at Primo Medical Group, Stoughton, MA Jun 2013 –Dec 2013

• Assisted in the design and building of manufacturing, assembly, and processing equipment

• Analyzed and resolved manufacturing problems in the clean room

• Involved in six-sigma, statistical capability studies, continuous manufacturing improvement, and safety

• Supported continuous improvement by identifying and addressing opportunities to reduce costs and improve overall clean room operations

Student Intern at Shanghai Fast-PCB Information Technology Company Jun 2007- May 2008 Jun 2008 – May 2009

• Participated in the design process of the PCB board with the design team

• Assisted senior project manager in the analysis of SPC data and the purposes for research

• Participated in new product development initiatives by providing manufacturing engineering support to assigned projects


University of Massachusetts Amherst – Amherst MA

Bachelor of Science in Mechanical Engineering May, 2016

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