Xtant Medical

Supply Chain Support Technician – Hardware

Title: Supply Chain Support Technician – Hardware
Status: Full-Time, Non-Exempt
Hardware Operations Manager
Location: Belgrade, MT

Summary:

Job Posting for Supply Chain Support Technician – Hardware

To apply for this position, please visit our company Careers Page at https://xtantmedical.com/careers/

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 Supply Chain Support Technician that will support the company mission to market regenerative medicine products and medical devices.  This position is responsible for supply chain activities with specific focus on production and manufacturing tasks. Tasks may include, but are not limited to receiving, shipping, inventory control, and coordination of supply disbursement.

This position supports the Hardware Operations department, at the production and processing level, to help ensure that Xtant Medical is compliant with the Food and Drug Administration (FDA), American Association of Tissue Banks (AATB), International Organization of Standardization (ISO) 13485, standards and other regulatory agencies as applicable.

This position supports the activities of the Hardware Operations Manager or appropriate designee.  This position interacts with employees in the Hardware Operations department and may interact with other department supervisors, team leads, and employees as necessary.

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
  • Adhere to Xtant Medical Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
  • Develop and maintain an understanding of Xtant Medical products and general hardware fulfillment and distribution 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
  • Support Xtant Medical’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients
  • Read, review, and maintain an understanding of the company quality manual and know where it is located
  • Perform all duties according to Xtant Medical SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures
  • Maintain required information in appropriate databases
  • Complete annual SOP review and OSHA safety training and ensure team members have completed the necessary reviews and training
  • Administer and report on hardware inventories
  • Follow SOPs, AATB standards, and FDA regulations while performing assigned duties
  • Execute timely operational tasks to support dependable communication between coworkers and customers
  • Always maintain a clean and safe working environment and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPs
  • Perform and ensure team performs Quality Control (QC) as required by Xtant Medical SOPs
  • Complete daily shipping and receiving transactions in the ERP
  • Ensure all material requisition orders, regular sales orders, and transfer warehouse orders are fulfilled on a regular basis
  • Record and store documents in an organized and efficient manner
  • Assist maintaining a series of logs utilized by coworkers and customers
  • Understand and execute all Supply Chain activities such as stock take, physical inventory count, inventory accuracy in allocation and consumption, material demand, sales order entry, and purchase order entry if needed
  • Assess and manage inventory levels to ensure continuity of supply
  • Maintain work order management system and understanding of production work order / material commitment, and back flushing
  • Will assist in Purchasing and/or HW Operations daily tasks when necessary
  • Assist in month-end close as needed

Position Requirements

  • Strong attention to detail
  • Strong organization and time management skills
  • Ability to focus on task at hand and work with minimal supervision
  • Aware of current Good Quality System Regulation (QSR)
  • Advanced ability to communicate effectively both orally and in writing
  • Ability to effectively utilize Microsoft Office programs; MS Excel, MS Word, MS Outlook specifically
  • Understanding of Enterprise Resource Planning systems (ERP)
  • Demonstrate expertise in a variety of the field’s concepts, practices, and procedures
  • Ability to utilize experience and judgment to plan and accomplish goals
  • Must be able to reason independently and work with minimal guidance
  • Ability to interpret data and make sound judgments based on those interpretations
  • Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
  • Must be able to adapt to quickly changing priorities and schedules
  • Ability to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authority
  • Must have excellent manual dexterity and good eye/hand/foot coordination
  • Must be able to lift, push, and pull 75 lbs.
  • Familiar with standard team lifting protocols when necessary

Education/Knowledge/Skills Required

  • High School diploma, or equivalent is required
  • 0-2 years’ experience with relative job duties is preferred
  • Basic financial and inventory experience is preferred
  • Prior knowledge of supply chain and manufacturing processes is preferred
  • Technical knowledge of orthopedic hardware and protocols and procedures is preferred
  • Knowledge of FDA 21 CFR 820 Quality System Regulation and ISO for Medical Devices is preferred
  • Experience with records maintenance and document control is preferred
  • APICS certifications preferred: CSCP, CPIM

Benefits:

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

 No H1B Sponsorships Available for this Position

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.