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Global Labeling Expert / Business Analyst / Process Improvement

Location:
Milford, NH
Posted:
February 08, 2016

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Resume:

CONTACT INFORMATION

Jeffrey R. Langelier

** ***** ******

Milford, NH 03055

USA

Home phone: 603-***-****

Mobile phone: 603-***-****

E-mail: actf9o@r.postjobfree.com

URL:

https://www.linkedin.com/in/jeffreylangelier/

SUMMARY

Business Analyst specializing in medical device product data. Extensive experience in all aspects of product labeling and data. Proven leader in requirements gathering and on-time deployment of cost saving compliance systems. Accomplished global traveler, trainer, and mentor. Engaging communicator with both technical and non-technical clients across many diverse cultures.

• GS1 / UDI / FDA GUDID compliance and data management

• GS1 verification

• Product labeling development and SDLC for web-based applications

• Subject Matter Expert (SME) for all labeling hardware, software, and supplies

• Cross-functional project management and team leadership

• Cost saving process improvement

• Hardware and software requirements validation

• Global data entry, data control, and data management

TECHNOLOGIES

Software: MS Office Pro, MS Lync, Adobe Acrobat, MS Visio, SharePoint, Service Now, Prisym Medica Web, NiceLabel, Bartender, LabelView, CodeSoft, EasyLabel, LabelMatrix, InDesign, Adobe Photoshop

Hardware: Thermal printers, barcode scanners, barcode validators, print and apply machines

PROFESSIONAL EXPERIENCE

MEDTRONIC, Mansfield, MA

2015 - 2015

Global UDI/GS1 Specialist, Corporate Engineering (Contract Employee - Via US Data Management)

On-site global travel to manufacturing sites. Document and manage the SDLC for Prisym Medica Web, a shared global labeling and data management system. Cross-functional collaboration and team leadership. Educate and train on GS1 / UDI global labeling compliance and data. Consult on best practices for product labeling hardware and supplies. Train and implement web-based product labeling software and related hardware.

•Monitor, evaluate, and recommend improvements to labeling processes and data management

•Improve existing and implement new technical documentation

•SME for Prisym Medica Web training and support and related hardware

STRYKER, Kalamazoo, MI

Senior Business Analyst, Global IT (Contract Employee - Via OnStaff USA) 2015 - 2015

Senior Business Analyst, Global IT (Full Time Employee) 2014 - 2015

Business Analyst, Global IT (Contract Employee - Via Impact Business Group) 2011 - 2014

On-site global travel to manufacturing sites. Document current as-is processes related to medical device labeling and data management. Document requirements and manage the SDLC for Prisym Medica Web, a shared global labeling and data management system. Cross-functional collaboration and team leadership. Document and map data migration plans for all data related to medical device product labeling. Educate and train on GS1 / UDI global labeling compliance. Develop and execute controlled test scripts at each stage of the implementation and validation of hardware and software. Train and implement web-based product labeling software and related hardware.

• Generated significant cost savings during the initial site deployment of a new global labeling and data management system.

• On time and under budget deployment of the Neurovascular global labeling and data management system across global sites

• On time and under budget deployment of the Turkish labeling system in Venlo Netherlands distribution center

• Developed a global labeling software user training manual being used by all divisions globally

• Promotion to Senior Business Analyst

BOSTON SCIENTIFIC, Marlborough, MA

Labeling Design Specialist II, Packaging and Labeling (Contract Employee)

2010 - 2011

Developed, reviewed and edited medical device Directions For Use (DFU). Ensured all data required for product labeling, DFUs, and equipment manuals met all required legal, regulatory, clinical, and marketing requirements. Established parameters to introduce new products into the corporate labeling software and related Standard Operating Procedures (SOP). Established a need for translations as defined in the marketing and product specifications and managed the process from translation vendors. Coordinated related product labeling reviews with all disciplines. On-site installation and validation of labeling software and hardware at contract manufacturer sites. Understanding of Good Manufacturing Practices (GMP), regulatory, and IT quality system requirements.

• Monitored, evaluated, and recommended improvements to labeling processes

• Improved existing and implemented new technical documentation

• Completed a two year contract assignment in one year, which resulted in significant cost savings

MCWAIN TECHNOLOGIES, Milford, NH

Sales / Web Master / Graphic Design (Consultant)

2007 - 2010

Consulted on compliance labeling hardware and software, marketing materials, and website content. Marketed and sold labeling software, hardware, and labeling supplies. Collaborated and designed the company website and managed on-line sales. Performed on-site installations. Managed service contracts and repairs.

• Developed an on-line presence and increased company sales

• Established vendor and customer relationships though improved communication channels

INTEGRATED LABELING SYSTEM, Nashua, NH

Technical Support / Service Manager

2005 - 2007

Managed the day to day operations of a full service technical support, service dispatch, and depot repair department (8 reports). Marketed full service offerings nation-wide. Department of Defense (DOD) UDI implementation and validation. Performed advanced installations with Systems Engineers. Supported the sales team by providing technical presentations for hardware and software during on-site sales visits. Designed and managed two company web sites with the web development team.

• Increased service sales by $1.2 million over a three year timeframe

• Developed the company’s process improvement team and streamlined company processes

• Created a comprehensive Service and Support Department, including set-up, organization, and hiring

INDUSTRIAL LABELING SYSTEMS, Chelmsford, MA

Technical Support / Service Manager

1999 - 2005

Managed the day to day operations of a full service technical support, service dispatch, and depot repair department (6 reports). Managed telephone and on-site technical support for barcode labeling software, thermal printers, and barcode scanners. Designed custom labels according to customer specifications and barcode standards for medical devices, electronics, and food products. Conducted in-house and on-site software training and hands on printer training. Provided pre-sales technical support.

EDUCATION / TRAINING

B.S., Management of Information Technology

Daniel Webster College, Nashua, NH

GPA 3.45

•GTIN Allocation Rules – GS1 US University

•Mastering Adobe Photoshop - CompuMaster

•Essentials of Communicating With Professionalism - SkillPath

•NiceLabel Enterprise Software with HL7 Certification - Niceware International

•The Conference on Leadership Development & Teambuilding - SkillPath

•RFID Platform Technical Certification - Symbol Technologies

•Adobe Photoshop 6.0 / CS - NH Technical College

•HTML and Web Design - NH Technical College

ADDITIONAL RELEVANT INFORMATION

IIBA Member – International Institute of Business Analysis 2015 - present

NAPP Member - National Association of Photoshop Professionals 2006 - present

Flame’s Ride to Beat Diabetes – Volunteer / Webmaster and Graphic Designer 2003 - 2007



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