Quality Control Engineer

David A. Enman 508-***-****

*** ******** ****** ******, ** 01520 *****.*****@*******.***

OBJECTIVES A dynamic, highly motivated and professional Quality Control/Assurance Specialist with excellent

project management experience, working to the highest FDA standards of compliance in the

manufacturing sector, possessing excellent communications and interpersonal skills, now seeking

suitable position.

EXPERIENCE CFR Part II, Certified ISO 13485:2003 Auditor, Project Management, Quality Control, CAPA,

Complaints, Equipment Control, Root Cause Analysis, Corporate Training,, Application Software

Development, Database Administration and Design, Custom Programming, Mechanical Drafting &

Design

TECHNOLOGIES TrackWise, C#.NET, VB.NET, ASP Programming, SQL Server, ORACLE, MS Access, MySql, PHP,

XML, COM Objects, VBA, HTML, JavaScript, Crystal Reports, Website Creation & Administration,

AutoCAD, Mechanical Desktop, Pro/Engineer, Solidworks, CADRA, Microsoft Office, FrontPage,

EDUCATION

Expected June, 2013 Fitchburg State University, Fitchburg, MA

M.B.A with Concentration in Quality Management

May, 2012 Framingham State University, Framingham, MA

B.A. with Concentration in Research

1995 Becker College, Worcester, MA

A.A. Liberal Arts

CERTIFICATIONS

2012 Root Cause Analysis Qualitative Problem Solving

2010 ISO 13485:2003 Auditor – British Standards Institution (BSI)

2008 Crystal Reports Development

2007 Sparta Systems Advanced Configuration and Administration of TrackWise

2005 Certificate Program Enterprise Application Development (C# & J2EE) - Clark University

2000 Client/Server Technology Certificate Program and NT Administration - Worcester Polytechnic Institute,

1997 Auto Lisp Training- New England Institute of Technology

1995 Mechanical Drafting and Design Technology - Worcester Institute of Technology

EMPLOYMENT

Hologic, - Marlborough, MA 10/10 – Present

Quality Control Systems Engineer & TrackWise Administrator

• Conduct Internal Audits per ISO 13485:2003

• Plan and direct activities concerned with development, application, and maintenance of quality standards for industrial

processes, materials, supplier engineering, purchasing, and products

• Create statistical reports to assist with the Quantitative & Qualitative analysis based on information collected in various

databases to forecast: inventory, staffing, and budgeting demands

• Devise methods to assess cost and disposition of discrepant material

• Develop and conduct corporate training on quality control activities

• Develop and initiate standards and methods for inspection, testing, and evaluation

• Configure, Document, Support, and Train all Quality Management related processes

• Processes include: CAPA, Complaints, Equipment Control, Internal Audits, Manufacturing, Nonconforming Material,

Supplier Audits, Returning Material

Hologic, - Marlborough, MA 08/05 – 10/10

Calibration Coordinator,

• Programs Used: TrackWise, GageInsite, SQL Server, Crystal Reports

• Converted Calibration & Preventive Maintenance system to be fully automated in TrackWise

• Included automated monitoring, tracking, and cost analysis for the entire International Community as well as Internal

Equipment Usage for nine divisions in four countries

• System included automated notifications, escalations, reports, certificates, and next Date Due generation based on

applicable frequencies.

• Contact for Field Service staff (approx. 350 field engineers) for the scheduling, assignment & retrieval of all equipment

• Converted Fixture Kits – including; deleting schedules, updating locations, assigning status

• Conducted inventory audits

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David A. Enman 508-***-****

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Charter Communications, - Worcester, MA 06/04 – 08/05

Senior Data Analyst

• Designed and implemented Call Center Virtual Web Reporting mechanisms

• Position required constant communication with all departments; mainly Sales, IT, and Operations

• Created automated data retrieval processes with custom queries for online reporting and commission/payroll

calculations

• Used VB 6.0 & Visual Studio.NET to create custom online reports

• Used MS SQL Server 2000, ORACLE, MySQL, and MS Access as backend for cross platform applications

• Created and maintained all stored procedures used for all Client/Server and web-based applications

Rizzo Associates, Inc., - Framingham, MA 05/02 – 06/04

Senior Technical Developer

• Ensured that proper training and growth opportunities exist for project specific deadlines

• Created statewide MHD Facility Auditing software using Visual Basic, MS SQL Server 2000, Xml

• Created custom GIS data maps connected via localized database to AutoCAD drawings to be used in field on tablet pc

• Created online survey forms for Transportation design

• Assisted in establishing drawing numbering system and archive network as well as developed standards and

procedures

• Automated Outlook Exchange message retrieval and database services

• Created/Supported applications for Staff using Visual Basic, SQL Server 2000, COM Objects, VBA, and MAPI

Controls

• Constructed automated Human Resources procedures using custom ActiveX Objects within xHtml Forms

BrassRing Systems, - Waltham, MA 06/00 – 05/02

Software Engineer

• Created/Supported applications used by Production Staff using Visual Basic, SQL Server 2000, COM Objects, XML

• Created/Supported applications used by Production Staff in conjunction with Kodak Microfilming

• Created/Supported software which used Barcode transactions on web with S400 and S600 Zebra Label Printing

machines

• Created Production Monitoring applications, posting results on web

• Created alarm mechanism for all web based monitoring applications; pages/notifies staff if theoretical thresholds

exceeded

• Worked closely with Networking and Data Center Group to support Citrix and Production Servers

• Created applications that Archive/Maintain Production Data on Servers from remote locations

Rizzo Associates, Inc., - Natick, MA 11/98 – 6/00

CADD Operator/Application Developer

• Constructed company Intranet using Visual Basic, SQL Server, AutoCAD, and ASP

• Created/Supported documentation and web viewable drawing files (DWF) of all released designs and drawings

• Created Project Tracking System using Visual Basic and Access ‘97/2000

• Created presentations and provided technical training and support

• Additionally performed CAD Drafting for Process Engineering and Survey Engineering Groups

Daymarc, Inc., - Littleton, MA 03/97 – 11/98

CADD Operator/ Assistant CAD Manager

• Constructed company website

• Provided software support/training to staff, customers, and vendors

• Responsible for detailing work using AutoCAD 12-14, Pro/PDM, and Pro/Engineer for Microchip design and

assembly

• Created a working library of 3-Dimensional solid objects for all product lines

• Created/Supported Auto Lisp programs

• Trained in Frontpage/Adobe Photoshop for website development

Wright Line, - Worcester, MA 05/95 – 03/97

Assistant Product Manager/ CAD Draftsman

• Served as a liaison for Engineering, Manufacturing, Purchasing during Product Development Lifecycle

• Conducted feasibility studies for requested special projects from sales staff

• Developed new Product Catalogs/ Building Plans for company and clients

• Provided sales/space planning support for Asia, Australia, Canada, and United Kingdom divisions

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