Xtant Medical

Quality Engineer – Supplies

Title: Quality Engineer – Supplies
Status: Full-Time, 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:

Supply Chain Management

  • Support supplier quality management programs, including more substantive hands-on problem solving and continuous improvement initiatives to raise performance/productivity with suppliers and supply chain
  • Own, maintain and report on corporate Supplier Ratings process for strategic suppliers.
  • Refine and maintain Xtant Supplier Survey documentation.
  • Work with Engineering, Sales, Regulatory, and Fulfillment to ensure effective problem resolution relating to supplier product/services.
  • Define and establish Xtant Medical Supplier Change Request (SCR) process
  • Evaluate and determine internal requirements for approval of all specific SCRs and facilitate the flow of required activities
  • Lead and maintain Supplier Audit Process, working with the Regulatory Department. Manage all audit and non-conforming product corrective actions (i.e. SCAR)
  • Coordinate and own the Approved Supplier List/process, including audit for non-compliance/renewals and revisions as required
  • Coordinate Supplier Quality Agreement Process in conjunction with Legal and Regulatory as required. Work with critical suppliers to develop relevant Control Plans, PFMEAs, Work Instructions and Acceptance Standards

Supply Chain Development

  • Support vendor selection/advanced surveillance/risk assessment. Ensure that suppliers’ manufacturing and quality systems, special processes and products meet purchase contract requirements and applicable regulatory and government regulations
  • Work with Engineering to develop proper key characteristics on drawings
  • Coordinate First Article inspection and qualification activities, including on-site assessment of supplier production process and controls if necessary

Knowledge/Skills Required

  • Professionalism and strong communication skills
  • Attention to detail and quality control
  • A basic knowledge of ISO 13485 Medical Devices – Quality Management System and FDA 21 CFR Part 820 Quality System Regulation
  • Must be proficient in Geometric Dimensioning and Tolerance
  • Working knowledge of Metrology – skills and measuring systems
  • Understanding of Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)
  • Excellent Statistical Analysis ability to enhance making various quality improvement plans
  • Experience with manufacturing ERP systems
  • Ability to manage multiple tasks, effectively utilize PC applications and have a sense of urgency in a fast-paced environment
  • Strong initiative and leadership skills required

 

Education 

  • Bachelor’s in Engineering, Master’s degree preferred
  • Minimum 3-4 years’ experience in a management role

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.