Xtant Medical

Quality Assurance Technician – Final Labeling/DHR

Title: Quality Assurance Technician – Final Labeling/DHR
Status: Full-Time, Non-Exempt
Location: Belgrade, MT

Summary:

Customer First. Employee Direction. Building Strategic Value. Respect for Gift of Donation.

Why Xtant Medical?

JOIN A RISING organization that unites exceptional biologics with intuitive fixation design to inspire surgical solutions that advance regenerative medicine. Our vision is to be the leader in regenerative medicine by continuously elevating the standard of care. Xtant Medical’s mission is to develop, acquire, manufacture, and commercialize innovative, quality regenerative surgical products for the treatment of degenerative, traumatic, and deformity conditions for orthopedic and neurological applications.

Principle Duties & Responsibilities

  • Review incoming Device History Records (DHR) for accuracy, completeness, and conformance in accordance with procedures and shipping and production schedules.
  • Ensure product specifications are met on incoming documentation.
  • Perform non-conforming material processes per internal procedures.
  • Perform labeling inspection and sampling of products as required by documented procedures.
  • Communicate effectively with QC, Fulfillment, and Supply Chain personnel to determine priorities.
  • Complete Trace Ability Documentation associated with ISO and FDA Regulations
  • Ability to manage multiple tasks, effectively utilize PC applications and have a sense of urgency in a fast-paced environment
  • Communicate effectively with suppliers to resolve incoming documentation issues.

Knowledge/Skills Required

  • Professionalism and strong written and verbal communication skills
  • Ability to read engineering drawings, as well as interpret and apply GD&T Tolerancing to raw data results is required
  • Working knowledge of ISO 13485 Medical Devices – Quality Management System and FDA 21 CFR Part 820 Quality System Regulation is highly desirable
  • Strong attention to detail while maintaining high quality standards is required
  • Must possess strong organizational skills
  • Strong Customer Service skills
  • Experience with record review and audit of written records is preferred

Education

  • 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

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.