Engineer Quality

James Foster

**** ****** **, ******, ** ***** ? 617-***-**** ? **********@*****.***

Education and Certification

University of Wisconsin - Madison

Madison, WI

Bachelor's Degree in Industrial and Systems Engineering, Graduation Date:

5/09

2005 - 2009

ASQ CQE

Received the ASQ Quality Engineering Certification

December 2011

Work Experience

Corindus Vascular Robotics

Waltham, MA

Senior Quality Engineer

March 2013 - Present

. Authored Quality Plans and Risk Management Plans for New Product

Development

. Co-authored an Integrated Business Plan for a New Product Development

Project

. Leading FMEA and Risk Analysis Documentation effort for New Product

Development

. Authored QMS Procedures including Process Control, Inspection, NCMR,

and Product Development/Design Change Control

. Responsible for all In Process and Incoming Inspection NCMRs,

Investigation Activity, Corrective Action, and NCMR Closure

. Involved with Corrective and Preventative Action (CAPA) Ownership,

Activities, Implementation, and Verification of Effectiveness

. Directly Managed one In Process Inspector - Coordinated Inspection

Activity, Training and provided Engineering Support

. Directly involved with BSI Microbiological Audit and responsible for

completing Corrective Actions based on feedback

St. Jude Medical/Lightlab Imaging

Westford, MA Quality Engineer II - Cardiovascular and

Ablation Technologies Division

March 2012 - March 2013

. Promoted to QE II after two years as a QE I (see below)

. Core Team Member for Site Transfer Validation Activity

. Core Team Member for New Product Development, Validation, and Release

. Authored MVP and MVR Documents for New Product Launch

. Co-Authored FMEA Documents

. Process Validation Team Member: Wrote, Reviewed, and Approved IQ, OQ,

PQ, PPQ, T/IMV Protocols and Reports

. Provided Quality Engineering support for successful completion of two

FDA Inspections with no 483 Observations

. Developed and Edited Quality System Documents, Procedures, Work

Instructions, and Forms

. Provided Engineering Support, Managed Training Activity, and

Coordinated Inspection Tasks in Supervision of the QC Inspection group

(nine Inspectors and one Quality Technician)

Quality Engineer I - Cardiovascular and Ablation Technologies Division

February 2010 - March 2012

. Received a Divisional Award of Excellence in February 2012 for

continually exceeding expectations

. Originally employed by Lightlab Imaging, acquired by St. Jude Medical

in July of 2010

. Improved/Developed Manufacturing Work Instructions and Inspection

Procedures

. Inspected, Tested, and Wrote Investigation Reports for Imaging Catheter

Post Sterile Testing failures to determine Root Cause

. NCMR Administrator: Responsible for all Disposable Catheter

Nonconforming Material Reports and NCMR Closure

. Completed monthly reports for Disposables NCMRs and QA Inspection

Metrics included in Risk Indicator Reviews

. Analyzed data and wrote reports to support QA Activity for NCMR

Investigations, CAPAs, and Engineering Change Requests

. Created and Corrected Quality Control Practices and Test and Inspection

Methods using Capability Studies and Metrology Concepts

Environmental Health & Safety Department - University of Wisconsin

Madison, WI Emergency Safety Equipment

Tester June 2008

- June 2009

. Inspected and tested emergency shower and eyewash stations on campus

. Recorded inventory for fire suppression systems and updated the fire

extinguisher databases using MS Access

. Inspected campus buildings for fire code violations, created and sent

violation reports, and tracked corrective actions

. Worked up to 20 hours/week during the academic semester and also given

the responsibility to recruit a replacement

Field Resources, Inc.

Needham, MA

Land Surveyor and Crew Chief

June 2003 - August 2006

. Promoted to Crew Chief in 2006 after three summers as a crew member

. Responsible for two people and 80% of the company's field work

. Prepared Certified Plot Plans using AutoCAD, As-built Certifications,

and Height Certifications

. Surveyed residential projects providing layout for new construction and

topographical information to contractors and builders

Skills & Interests

. Proficient with Minitab, Windchill PDM, Agile, EpiCor, SAP, and EtQ

software

. Played and coached competitive Ultimate Frisbee for 10 years

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