Documentation Specialist

Documentation Specialist

Create, 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 available 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 :

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.