Documentation Specialist

Teleflex

  • Wyomissing, PA
  • Permanent
  • Full-time
  • 17 days ago
Expected Travel: NoneRequisition ID: 12631About Teleflex IncorporatedAs 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.Vascular Access - Built on a history of innovation, our Arrow® brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular-related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.Position SummaryCreate, revise, review and release Device Master Records, Material Master configurations, and documentation associated with product lifecycle management required to purchase, manufacture, and distribute medical device products.Principal Responsibilities
  • Serve as Change Analyst and/or Data Steward within the PLM, ERP and UDI database systems - Agile, SAP, DSD.
  • In coordination with engineering teams, prepare new and revised product DMR and MM configurations and documentation using the required PLM, ERP and UDI database systems - Agile, SAP, DSD.
  • Review DMR-related documents and attachment files submitted for creation or changes. Standardize format, proofread for errors/clarity and verify configuration.
  • Review change management activities for adherence to applicable change management procedures and cross-functional approval levels.
  • Follow regulatory requirements, internal procedures and the most recent and best practice guidance avaialble in the areas of Design Control, DMR, change management, and inspection.
  • Create or revise inspection documentation in the PLM and ERP database systems - Agile, SAP.
  • Process electronic DHF documents in the PLM database. Review documents for formatting, clarity and adherence to GDP.
  • Generate/analyze metrics associated with the PLM database and other department work, as required.
  • Provide other department support as required by immediate supervisor.
  • Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
Education / Experience Requirements
  • HS Diploma or equivalent
  • Experience or AS - technical discipline preferred
  • 0 - 4 years experience in documentation, data analysis or database systems
#LI-LP1Specialized Skills / Other RequirementsAt 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 Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, 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.
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Teleflex