Enable America Jobs

Documentation Specialist

Date: Aug 13, 2024

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel : None

Requisition ID :10799

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com .

Global Functions – The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Review and critique documentation for new, revised, custom, and foreign products for complete official documentation records required to manufacture medical products.

Principal Responsibilities

• Serve as Change Analyst and/or Artwork Data Manager and/or Data Steward within the PLM, VERACITI, ERP, and UDI database systems - Agile, SAP, DSD (Lansa), and VERACITI (Kallik). Activities may include the following:

• In coordination with the Engineering team, prepare new and revised product DMR and MM configurations and documentation using the required PLM, ERP, and UDI database systems—Agile, SAP, and DSD.

• Manage Pilot/Prototype ECOs, Production ECOs/ECRs, Sustaining Change ECOs/ECRs, MCOs, ADCs, DMR review, SAP/Pre-Checks (MM Forms/Lansa Input Forms), SAP review, IPN and GTIN management, DSD registrations/publications.

• Review DMR-related documents and attachment files submitted for creation or changes. Standardize format, proofread for errors or clarity, and verify configuration.

• Submit documents for approval signatures, coordinate corrections and changes by approvers, and issue documentation package(s). Update appropriate personnel on open projects as required.

• Assist and communicate with engineering, marketing, and regulatory bodies in preparing new or revised product documentation packages. Assist in formalizing documentation, as required.

• Generate product labeling in VERACITI. Proofread product labeling in coordination with the labeling team to ensure adherence to internal labeling procedures, accuracy, completeness, and formatting.

• Import and maintain current, accurate files for figures, graphics, and scanned images required for product labeling.

• Follow regulatory requirements, internal procedures, and the most recent and best practice guidance available in Design Control, DMR, change management, and inspection.

• Process electronic DHF documents in the PLM database. Review documents for formatting, clarity, and adherence to GDP.

• Provide other department support as required by the manager.

• Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

• High School Diploma or equivalent required. Bachelor’s degree preferred.

• 2+ years relevant experience. A combination of education and experience will be considered.

• Experience in regulated industry highly preferred.

• Experience with PLM (e.g., Agile), ERP (e.g., SAP), VERACITI (Kallk), and/or UDI (e.g., Lansa) systems a plus.

• Working knowledge of Illustrator a plus.

Specialized Skills / Other Requirements

• Intermediate knowledge of Microsoft Suite, specifically Word and Excel.

• Solid organizational skills and strong attention to detail.

• Proven ability to learn new systems and processes.

• Effective communication skills, both verbal and written.

• Proven team player and customer service oriented.

• Demonstrated sense of urgency.

• Ability to work in a fast-paced, dynamic environment.

• Ability to adapt to changing priorities.

• Ability to multi-task and work with competing priorities highly preferred.

#LI-DR1

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.

Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2024 Teleflex Incorporated. All rights reserved.