Medical Device Engineer
Resume:
LINDA MCINNIS, P.O. BOX ***,
ALBANY, VT *****
************@*****.***
SR. QUALITY ENGINEER & TECHNICAL WRITER
Skills
OBJECTIVE GMP / GLP / GCP
Seeking a position where I can build and execute: Adobe Photoshop
• test cases, plans and strategies, Adobe Flash
Eclipse IDE
• infrastructure, processes and procedures
MS Office Suite
to build superior quality application or medical device software. Open Office
Java (reading)
EXPERIENCE Simple Scripting:
JavaScript
Software Quality Matters, LLC, Consultant Software Test Python
Shell scripting
March 2013 - present
XML
Visual Basic
• Create test cases for non-medical devices such as web marketing products HTML/XHTML
•
Write and Run software V& V test cases for Software in client Medical devices according to
Oracle
FDA Quality Regulations 820 and ISO 13485 Sybase
SQL
• Create FMEA, Traceability, Test procedures, protocols, Hazard and Risk analysis
TeamCenter
Software Test Engineer, Medical Device March 2011 – March 2013 Code Collaborator
Confluence
Volcano, Billerica, Massachusetts
JIRA
DOORS
• Write Sprint tasks, Team using Agile Methodology Clearcase
• Cvs
Write and Run manual software V& V test cases for this Medical Imaging product
Fogbugz
• Created FMEA, Traceability, Verification Plans, Hazard and Risk analysis. Subversion
• Wrote defect reports, helped clarify specifications, reviewed IFU and Operator manual Redmine
PVCS
Lotus Notes
Contract Technical Writer, Data Warehouse March 2011 – April
UML
2011 Dataupia, Cambridge, Massachusetts Use cases
Linux/UNIX
Revised Release notes for the Satori server. Windows Vista/XP
Mac
iPhone
Instructor, Software Engineering Masters program March 2009 – August 2011
iPad
Brandeis University, Waltham, Massachusetts
Quick Test Pro
Test Complete
Taught a course online titled Foundations of Software Quality Assurance in the Graduate Software Silktest
Engineering Program.
Certification
Software Quality Engineer, Medical Device February 2010 – February 2011 Six Sigma – Green
Belt
Haemonetics, Braintree, Massachusetts
• Wrote and ran manual V& V test cases for medical device and Mobile Data Transfer
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• Create Traceability Matrices from SRS to tests in DOORS
• Software Validation plan, bug reports, testing reports
Software Quality Engineer, Medical Device April 2008 to October 2009
Instrumentation Laboratory, Bedford, Massachusetts
• Wrote manual Test Scripts and manually tested a Linux-based Blood Gas Analyzer
• Entered bugs into PVCS Tracker, generated metrics, Participated in Change Control Board
• Created an analysis of Software Compliance Risks
Sr. QA Engineer\QA Lead, Medical Record October 2007 to April
2008
Document Management
Sceris, Inc., Sudbury, Massachusetts
• Tested this Document Management software and collateral programs manually and using
automated test scripts written in Silktest. Updated and wrote new Silktest scripts.
• Wrote test plans, entered bugs in QA Radar.
• Reviewed Documentation
• Worked with Support on problem escalation and resolution.
Sr. QA Engineer, Medical Device 2005-2007
Boston Scientific, Natick, Massachusetts
• Provided Regulatory Software Validation and Verification for this medical device company.
• Wrote Validation and Test Plans per FDA regulations, Reviewed specifications, Built
traceability matrices,
• Provided development process regulatory oversight.
• Developed an enterprise-wide educational program for understanding the business model,
products and critical thinking for working in regulated environment through a program called Lunch
and Learn.
EDUCATION / CERTIFICATIONS
Regulatory Affairs, Certificate Currently in progress
San Diego University, San Diego, California
Six Sigma, Green Belt 2005
Value Train, Atlanta, Georgia
Physics, Bachelor of Science
Worcester Polytechnic Institute, Worcester, Massachusetts
Studies focused in geophysics and oceanography.
Major Qualifying Project: produced fault plane depiction of tectonic activity in Baja California.
Interactive Qualifying Project: created science demonstrations for the Worcester Science Center.
Minor: English
Work Study: Editorial Assistant for the Journal of Theoretical Biology.
Linda McInnis Resume Quality Matters 2
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