Medical Device Labeling Specialist

RITA MISTRY

Hard-working and reliable professional with 8+ years of Labeling Experience in the medical device industry. Strong ability to work well under pressure, adaptable approach, and drive for results.

TECHNICAL SKILLS

●Microsoft Office Word, PowerPoint, Excel, Access, Desktop Publishing – Advanced

●Adobe - Acrobat, Illustrator, In-Design, Photoshop.

●EZ Label

●Oracle Agile, JD Edwards (E-1) - AS 400, AVAYA Aura Agent Desktop (AAAD), Salesforce.com (SFDC),

●SAP, Master Control.

WORK EXPERIENCE

CSI Interfusion Inc. - Microsoft

Data Labeling Specialist, Contract

June 2024 to Aug 2024

●Spearheaded Projects focusing on developing and implementing Natural Language Processing (NLP) techniques to detect hallucinations in machine-generated text, ensuring the generation provides accurate and reliable information.

●Tackled challenging issues related to hallucination and AI-generated content, devising strategies to improve the accuracy and quality of the generated responses.

●Oversaw data quality control measures and report any improvements or regressions, ensuring that it met the standards of performance.

●Effectively communicated the results of hallucination detection efforts to stakeholders and collaborated with other data analysts on how to improve further results.

●Managed multiple projects, prioritized tasks, and met deadlines while upholding the highest standards in hallucination detections.

●implement the use of ChatGT to generate work distribution.

MasTech Digital – Hologic Inc - Marlborough MA

Associate Global Labeling Specialist, Contract

August 2021 to March 2024

●Work closely with authors, import text and images and create layouts in both Microsoft and Adobe software programs.

●Follow established style guides and templates.

Create digital and print materials such as forms, reports, information graphics, presentations, and website imagery.

●Develop, modify, and maintain documents.

●Prepare formatted documents for print or electronic publication.

●Establish and maintain version control, file access permissions and electronic file archival.

●Archive proposal materials upon submission of bids.

●produce documentation including process flow diagrams, procedures, and other published materials.

Sunrise Systems Inc. – Becton Dickinson (BD) - Warwick, RI

Associate Global Labeling Specialist, Contract

December 2020 to August 2021

●Manage Labeling Projects in all aspects of labeling and design changes for projects, including working with Department Managers on requirements to update labels and IFUs, translations, redlines, artwork updates in EZ label or Bartender, verifying barcodes using the barcode scanner, creating CR's and BAWs in Master Control, approvals, and additional related responsibilities.

●Experience with MDR, G-code, TGA updates and EU Exit.

●Same responsibilities as listed below.

Cor-Tech - Siemens Healthineers - Norwood, MA

Product Labeling Coordinator, Contract

October 2018 to September 2020

●Manage Labeling Projects in all aspects of labeling change projects, including working with Department Managers on requirements to update labels and IFUs, translations, redlines, part number requests, creating Engineering Change Notice (ECO) in SAP, approvals, and additional related responsibilities.

●Responsible for the successful implementation of the associated labeling deliverables, point contact for these projects for the labeling and documentation group and will work directly with other functions such as engineering, commercial organizations, manufacturing sites to coordinate all the required change management.

●Assist the Project Manager and subject matter experts to develop and execute an overall plan to coordinate change management of documentation related to operator guides, instructional documents, release notes, addendums, and customer bulletins in addition to the packaging and labeling deliverables to achieve the objectives of the project.

●Assist labeling project managers in all aspects of labeling change projects.

●Proofreading and reviewing print and electronic content deliverables for spelling, grammar, language/style consistency, regulatory compliance and other appropriate standards as defined by Siemens Healthcare Diagnostics.

●Work with a variety of cross-functional teams to develop customer documentation related to operator guides, instructional documents, release notes, addendums, and customer bulletins, Instructions for Use, and packaging and labeling deliverables to achieve the objectives of the project.

●Work with technical writing, labeling and core team to plan and facilitate editing and proofreading activities. Ensure all activities are managed in a time sensitive fashion.

Kelly Services - Medtronic – Mansfield, MA June 2016 - October 2018

Contracts Administrator, Contract

●Work within Excel and Access data sheets and researching current account numbers and address using the Partner (company database). Added and expired group accounts numbers in Partner.

●Transferring accounts from one GPO to another.

●Researching, Expiring and Adding member groups in Partner

●Peer auditing customer contracts including fees, eligibility, dealer services.

●Research and Add Contract Account Duplicate reports.

RGP – Medtronic’s – Mansfield MA

GDS Product Label Artwork Coordinator, Contract October 2015 - November 2016

●Assisting UDI Review process updating data sheets, distributing to printers and reviewers for proofing, tracking progress, reviewing for updates, redlines for designers, updating Agile with updates.

●Working with OEM team with working with outside vendors to ensure data is correct, pull any artwork from Agile, and work with RA and marketing with any updates that may be required.

●Working with Med Supplies day-to-day team with their day artwork procedures including prepping Job-sheets, redlines for designers, creating doc numbers and EC0#s in Agile.

UDI RMS Product Label Artwork Coordinator

June 2014 to October 2015

●Work with plants to verify artwork to make FDA UDI Compliant.

●Download most updated Artwork, ZIP and VDM from Agile. Collate artwork; address any artwork issues working with the plant and designers. Redline rebranded artwork for designers and VDMs verifying GTINs and Part numbers.

●Maintain Spreadsheets, and folder structure on Server to house uploaded Agile SKUs.

● Create EC0s and re-load updated VDM rebranded/relined UDI artwork to Agile for approval.

●Work with approvers to process ECO to Close.

BestPrintBuy.com - Norwood, MA

January 2014 - May 2014

Customer Service Representative

●Assisting customers on website questions/queries for www.bestprintbuy.com and any customer related issues mostly for real estate agents printing products.

●Working within bestprintbuy.com backend and verifying customer approved custom products and sending them ready for print.

●Call customers with any errors found within their product for correct data image. Report and QA any errors found within bestprintbuy.com website for updates to IS team.

Covidien - Mansfield, MA

Data Integrity Administrator

February 2010 - March 2013

Administrator, Contract

March 2011 - November 2011

Data Integrity Administrator, Contract

February 2010 - February 2011

EDUCATION

Microsoft Windows 2010

Word, Outlook, Excel, Access, PowerPoint - Advanced

August 2018

Agile Project Management UTI Online

April 2018

GED - High School Equivalency Credential Massasoit Community College - Brockton, MA

October 2013

SKILLS

●Ability to learn on the fly Ability to multi-task Graphical technical skills and ability Strong communicator.

●Organized Leadership skills Team player Strong drive to succeed.

Contact this candidate