Megan Martin is a highly qualified professional, that works in Djo Global main office of which is in 104. on the position of Software Consultant and Regulatory, Risk, Dhf, Technical File Remediation since 2018. Megan has earned professional experience in more than 44 positions at various companies. Megan Martin went to the Fairfield University and received education from 1998 to 2002. Granger, Texas is the city, where the professional was known to be settled. This professional's email address and phone can be accessed through Connexy by request.
Name variants:
Meg Martin
Contact Information
Last Update
Jul 14, 2022
Email
ma**@calamatainc.com, me**@accenture.com, me**@gmail.com
Location
Granger, TX
Company
Workplace
Software Consultant and Regulatory, Risk, Dhf, Technical File Remediation
Vista, CA
Industry
Medical Devices
Colleagues
Work History
Software Consultant and Regulatory, Risk, Dhf, Technical File Remediation
2900 Lake Vista Dr, Dallas, TX 75249
Risk Management, Software Quality, and Technical File Consultant for medical devices. Remediation of tech file and DHF for medical devices using including embedded software. Review and revis...
Oct 2018 — Dec 2018
Consulting Engineer, 510K Remediation and Software
750 north Daniels Way, Bloomington, IN 47404
Engineering Consultant for H-30 Holmium Laser Lithotripsy System. 510k remediation including work on requirements, risk, traceability and other DHF documentation. Investigation of root cause...
Oct 2016 — Aug 2017
Consulting Software and Quality Engineer
2790 Mosside Blvd SUITE 800, Monroeville, PA 15146
Founded in 2008, R&Q provides integrated quality and regulatory consulting solutions to medical device companies. We support the life-cycle of medical devices from conceptual development thr...
Aug 2015 — Sep 2016
Consulting Software Engineer
920 Winter St, Waltham, MA 02451
Fresenius Medical Care North America (FMCNA) is the premier health care company focused on providing the highest quality care to people with renal and other chronic conditions. Through its i...
Aug 2015 — Sep 2016
Consultant, Quality Systems
As part of a small team from MedTech Review (Consultants), define and implement a quality system for a medical device manufacturer. Implement an installation of QT9. Write SOPs and work inst...
Oct 2014 — Mar 2015
Volunteer: Coordinator and Director
Key volunteer serving as a Director / Coordinator for a national draft horse rescue 501c3 organization. Provide technical and marketing support for the organization. Work as a member of a 3-...
Jun 2014 — Jan 2016
Senior Consultant - Quality and Software and Risk and Regulatory - Medical Devices
257 Garnet Garden St, Henderson, NV 89015
Product evaluation for compliance to IEC 62304, ISO 14971, PEMS, 62304, 60601, 62366 and other relevant standards. Development of procedures, work instructions, templates at the corporate an...
Jun 2013 — Jul 2015
Software Quality Engineer
Software Quality Assurance on a left ventrical assist heart pump. Support development of embedded and PC based software for DuraHeart products, test tools and testing software. Support proce...
Mar 2013 — Jul 2013
Senior Quality Consultant, Manufacturing and Software and Csv
351 Phelps Dr, Irving, TX 75038
Define the Computer Software Validation (CSV) Process for manufacturing environment (Class I & Class II products). Conduct software validations on software for manufacturing equipment contro...
Oct 2012 — Apr 2013
Quality Architect and Software Qa
Quality Architect and QA support for software develompment in a .NET environment using Agile methods. Supporting development of breakthrough software products for the insurance industry (XML...
Jun 2011 — Oct 2012
Owner and Consultant: Sw Engineer and Quality and Test and Risk and V and V and Csv, Technician Writer, Fda,Med Device Class I-Ii-Iii, Mfg
SW Engineering, Quality, V&V and Test for a variety of clients including:
Medical Devices
FDA, 510k, Technical Files, 483 Remediation
Processes, SOPs, IQ/OQ/PQ, Tool Validation
V&V, Sof...
from Jun 2011
Senior Sw Quality Engineer
5200 Illumina Way, San Diego, CA 92122
Support quality process for multiple projects involving software. Review, support, train, and assist with development of documentation for Research Use Only and FDA Regulated products.
Mar 2011 — Jul 2011
Prin Sw Engineer, V and V
Device V&V, verification, validation, requirements, FDA 510k. Glucose Monitor, startup company.
Jul 2008 — Mar 2011
Quality Engineer and Sw V and V Specialist
821 Franklin Ave SUITE 301, Garden City, NY 11530
ECG / ultrasound device, start-up company. Advise on Quality and V&V issues for initial submission to FDA. Design and develop system and software validation. Assist with development of unit ...
Dec 2007 — Jun 2008
Senior Software Validation and Verification Engineer
710 Medtronic Pkwy, Fridley, MN 55432
Ventilator (Puritan Bennett, Tyco). Design and write verification and validation protocols. Verification & Validation: Ventilator design was purchased from the inventors in France and did no...
Dec 2007 — Jun 2008
Vice President - Marketing and Business Development
485 Lexington Ave, New York, NY 10017
Apr 2007 — Dec 2011
Sqa and Sqe Software Quality Assurance
100 Boston Scientific Way, Marlborough, MA 01752
Quality & Compliance: Guide project teams in complying with required software development process and ensure FDA- and ISO-compliant paper trail and electronic records during all phases of pr...
2007 — 2007
Sqa and Sqe Software Quality Assurance
Illinois
Quality & Compliance: Guide project teams in complying with required software development process and ensure FDA- and ISO-compliant paper trail and electronic records during all phases of pr...
2007 — 2007
V and V Software Test
33 Technology Dr, Irvine, CA 92618
Requirements: Review and revise Requirements and Specification documents for clarity, accuracy and testability. Verification and Validation: Design, write and execute test cases and procedur...
2006 — 2007
Technical Writer
38975 Sky Canyon Dr, Murrieta, CA 92563
Technical Writing: Created manuals and training materials for equipment used in the manufacture of Disc Drive Suspensions for disc drives less than 1" in diameter. Develop Operator, Technica...
2005 — 2006
Director of Marketing
7800 east Union Ave SUITE 400, Denver, CO 80237
Aug 2004 — Apr 2007
Sqe and Sqa Software Quality Assurance Engineer
275 north Field Dr, Lake Forest, IL 60045
Senior lead for department of 5 Quality Engineers: Train and supervise other Quality Engineers on multiple projects. SW Quality Process: Responsible for Software Quality process and data ana...
2003 — 2005
Software V and V Test
10210 Genetic Center Dr, San Diego, CA 92121
Verification & Validation: Write and execute test cases for blood analyzer system including hardware and embedded software. Review specifications for testability. Maintain requirements, test...
2001 — 2003
Sqe and Sqa, Quality, Software Test, V and V, Fda,Tech Writer, Ba, Pm, Illustrator
2000 — 2012
Technician Writer and V and V and Sqa and Fda
Quality Assurance Consulting: Brought in to remediate their development and quality process after FDA rejection of any additional submissions. Reviewed and redesigned development and quality...
2000 — 2000
Technician Writer and V and V and Fda and Qa
500 Burdick Pkwy, Deerfield, WI 53531
Regulatory and Quality Assurance Consulting: Reviewed FDA submission process and recommended modifications. Rewrote submission packages.
2000 — 2000
Sw V and V and Technician Writer and Ra and Qa and Web and Etc
17400 Medina Rd #100, Minneapolis, MN 55447
Corporate Process: Developed quality manual and development procedures for corporation. Developed corporate web site.
Design & Development: Research market needs. Wrote all requirements, s...
1997 — 2001
V and V and Software Test
formerly Bird Medical
Specification & Design: Reviewed specs and design docs for accuracy, completeness, testability.
Hazard / Risk Analysis: Drove hazards/risk analysis process and maint...
1994 — 1997
Development Lead
Software Designer / Team Lead: Designed and maintained student loan management system. Functional, system and database design and design documentation. Supervised other contractors.
1994 — 1994
Oracle Developer
Software Developer: Designed, developed and maintained applications in COBOL and Oracle including forms and ProCobol. Inventory management, order processing, patient records.
1993 — 1994
Software Developer
Software Developer: Designed and maintained Ingres (SQL) and COBOL software systems. Analyzed requirements, wrote specifications. Business Analyst: Analyze and define solutions for business ...
1992 — 1993
Software V and V Test
Requirements: Revised software requirements and specs. Verification & Validation: Reviewed software design and code. Wrote and executed software tests and system integration testing. Assiste...
1989 — 1992
Senior Sw Engineer and Group Lead
Group Lead / Acting Section Manager: Architecture and design for automated fingerprint ID and matching systems. Analyzed customer requirements and wrote specifications, user manuals and tech...
1987 — 1989
Software Group Lead
Group Lead / Acting Section Manager: Architecture and design for automated fingerprint ID and matching systems. Analyzed customer requirements and wrote specifications, user manuals and tech...
1987 — 1989
Education
1998 — 2002
1975 — 1978
Occupations
Executive
Team Leader
Director
Counselor
Engineer
Operations Manager
Advisor
Skills
Fda
Quality Assurance
Medical Devices
Quality System
Testing
Validation
V&V
Iso 13485
Software Quality Assurance
Design Control
Sdlc
Quality Control
Cross Functional Team Leadership
Software Documentation
Capa
Requirements Traceability
Quality Management
Iso 14971
Embedded Systems
Iso
Gmp
Manufacturing
Requirements Analysis
Change Control
Agile Methodologies
Sop
Technical Writing
R&D
Test Automation
Team Oriented
Computer System Validation
Software Development
21 Cfr Part 11
Biomedical Engineering
System Testing
Gamp
Specifications
Microsoft Excel
Gxp
Process Simulation
Test Planning
Project Planning
U.s. Food and Drug Administration
Team Leadership
Communication Skills
Powerpoint
Team Building
Iec 62304
Spreadsheet Validation
Business Development
Business Strategy
Marketing Strategy
Analytics
Crm
Strategy
Outsourcing
Marketing
Product Development
Lead Generation
Vendor Management
Team Management
Competitive Analysis
Strategic Planning
Sales
FAQs about Megan Martin
What's the main profession of Megan Martin?
Megan is a Software Consultant and Regulatory, Risk, Dhf, Technical File Remediation.
What are the main profession of The professional?
These person's professions are Executive and Team Leader
Where does Megan Martin live?
The professional lives in Granger, Texas.
What is Megan Martin's email?
Megan Martin's email is ma**@calamatainc.com and me**@accenture.com.
Where did Megan Martin work?
This expert worked at Djo Global, Accenture.
Where has Megan Martin studied?
Megan studied at the Fairfield University from 1998 to 2002.
What languages does Megan Martin speak?
Megan Martin speaks English.
Are there any special industries, that Megan Martin is connected to?
Megan Martin works in Financial Services industry.