Xtant Medical

Set Technician

Title: Set Technician
Status: Full-Time, Non-Exempt
Location: Belgrade, MT

Summary:

Why Xtant Medical?

JOIN A RISING organization that is focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal fixation systems. Xtant Medical’s mission is to provide cost-effective technology and services that help clinicians efficiently perform their job.

Position Summary

Xtant Medical is seeking a talented and dedicated Set Technician that will support the company mission to market regenerative medicine products and medical devices. The primary responsibility of the Set Technician is to perform activities related to inventory fulfillment, quality maintenance, and regulatory compliance in their department, as assigned.  This person does not supervise others and will support the activities of the Set Technician Team Lead and/or Manager.

This position works with the department team lead(s) and manager and with other Technician’s at the fulfillment and distribution level to help ensure that Xtant Medical complies with and meets the standards of the Food and Drug Administration (FDA) and International Organization of Standardization (ISO), and other regulatory agencies as necessary in distributing Xtant Medical inventory.

Principle Duties & Responsibilities

  • Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; European Medical Device Directives (MDD); and Canadian Medical Device Regulations as applicable and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice.
  • Develop and maintain an understanding of Xtant Medical products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable.
  • Perform Quality Control (QC) as required by SOPs.
  • Complete documentation of tissue storage locations and conditions as required and in accordance with Good Documentation Practices. During processing, appropriately store unprocessed and processed tissue in the designated location ensuring appropriate environmental conditions are maintained.
  • Assist with managing inventory warehouse counts utilizing cycle count program.
  • Follow OSHA bloodborne pathogen standards, universal precautions, AATB Standards, and current Good Manufacturing Practices (cGMP), and current Good Tissue Practices (cGTP) during all phases of processing packaging, storage and cleaning.
  • Daily Product Transaction Activities – inventory allocation within an ERP system, tracking and reconciling inventory returns to match finance and invoicing.
  • Maintaining tray inspection throughput to provide necessary inventory redistribution within a timely manner.
  • Receiving/Inspecting/Reprocessing of Surgical Sets and Reconciling Associated Documentation.
  • Building of Sets for Product Launches and Reconciling Associated Documentation.
  • Identifying Material Storage & Stock Locations.
  • Track Material with Limited Shelf Life or Expiration Dates to appropriately discard inventory if within expiration window.
  • Processing of returned trays from field:
    • Allocate new inventory from warehouse to fill empty tray items.
    • Transfer items missing in tray to Distributor’s MIA warehouse for invoicing.
    • Update lot numbers in all trays to properly track inventory.
    • Complete all associated documentation and tray second checks before returning to finished goods.
    • Report missing inventory items to invoicing to verify billing and transact records.

Position Requirements

  • Ability to manage multiple tasks and maintain focus to finish job to completion.
  • Ability to work in a fast-paced environment with a commitment to quality over quantity.
  • Demonstrated capability to communicate effectively both orally and in writing.
  • Ability to multitask.
  • Must possess excellent organizational skills and strong attention to detail.
  • Basic computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary.
  • Ability to investigate and analyze data to draw conclusions and drive solutions.

 

Education/Knowledge/Skills Required

  • Bachelor’s degree is preferred + 1-year minimum experience in QA functions and/or manufacturing, preferably in FDA-regulated industry, or equivalent experience is required.
  • ERP and automated document control experience is desired.
  • Basic knowledge of ISO 13485 Medical Devices – Quality Management System and FDA 21 CRF Part 820 Quality System Regulation.
  • Experience with manufacturing related Inventory Control software.
  • Experience with records maintenance and document control.

Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages

Xtant Medical is an equal opportunity employer.  We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors.