Medical Device Technician

1 month ago


Belgrade, Maine, United States Xtant Medical Full time
Job Title: Medical Device Technician

Xtant Medical is seeking a highly skilled Medical Device Technician to join our team in Belgrade, MT.

Job Summary:

We are looking for a detail-oriented and organized individual to perform activities related to inventory fulfillment, quality maintenance, and regulatory compliance in our department.

Key Responsibilities:
  • Perform inventory fulfillment, quality maintenance, and regulatory compliance activities in our department.
  • Develop and maintain an understanding of FDA regulations, ISO standards, and other regulatory requirements.
  • Adhere to Xtant Medical Standard Operating Procedures (SOPs) and safety protocols.
  • Support the activities of the Medical Device Technician Team Lead and/or Manager.
  • Assist with managing inventory warehouse counts using a cycle count program.
  • Perform Quality Control (QC) as required by SOPs.
  • 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.
Requirements:
  • High School Diploma or equivalent.
  • Professionalism and strong communication skills.
  • Attention to detail and quality control.
  • 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.
  • Ability to manage multiple tasks but maintain focus to finish job to completion.
  • Effectively utilize PC applications to complete required job function.
  • Understands sense of urgency in a fast-paced environment but commits to quality over quantity.
Working Conditions:

Working conditions are normal for an office environment. Standard office hours are Monday - Friday; 8:00 am - 5:00 pm. Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments.

Health and Safety:

Must adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products. May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable.

Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver.

Must be able to lift, push, and pull 80 lbs.



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