At Xtant Medical , our mission is to honor the gift of donation by allowing our patients to live as full and complete a life as possible. We are seeking a full-time, non-exempt Medical Device Technician - Inspection & Fulfillment to join our team on-site in Belgrade, MT. It offers a pay rate of $20/hour and includes the benefits listed below. If you enjoy working as a team and want to grow your career, you’ve found the right place at Xtant Medical!

Status: Full Time – Non-Exempt

Reports To: Medical Device Technician Team Lead

Benefits:

• Medical-Dental-Vision
• Generous PTO Schedule
• Corporate Gym Discount
• 401(k)
• Well-Being Programs / LifeBalance Discount Program
• Life & AD&D Life Insurance
• Long-Term & Short-Term Disability
• Tax Savings, plus more...

Responsibilities of the Medical Device Technician-Inspection & Fulfillment: (Included, but not limited to)

• Perform Quality Control (QC) as required by SOPs
• 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 an cleaning
• Daily Product Transaction Activities - inventory allocation within an ERP system, tracking and reconciling inventory returns to match finance and invoicing
• Maintaining tray inspection throughout 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 shelf
  • Report missing inventory items to invoicing to verify billing and transact records
• Upon hire, employee may rotate through support departments in order to learn various aspects of the department including decontamination, picking orders, packaging orders, shipping, product labeling and inventory decontamination
• Employee shift schedules may vary depending on the needs of the department and high peak order times
• Quarter and Year End dates are MANDATORY working days and will be outlined at the beginning of every fiscal year for the team to schedule vacation around
• Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees

Requirements for the Medical Device Technician - Inspection & Fulfillment

• High school diploma or equivalent is required
• 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
• Strong initiative and leadership skills needed
• 1-year of experience in QA functions and/or manufacturing is preferred, but not required
• ERP and automated document control experience is desired

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
• Work may require occasional weekend/evening work and 4 hours of continuous standing
• Shift times may change based on the current needs of the department
• Will operate magnification and inspection/laboratory equipment
• Employee may encounter contact with human tissue, blood, bone, and fluids

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

About Us:

We aim to improve the quality of life for our patients by designing, manufacturing and distributing medical devices and human tissues for transplants that are safe, effective and meet the needs of our customers.

Note: This Job Description is not designed to include a detailed listing of the activities, duties or responsibilities that may be required of the employee. This job description does not constitute an employment contract, implied or otherwise, and is subject to change by the employer as the needs of the employer and requirements of the job change.

This position does not offer current or future H-1B Visa Sponsorship

Xtant Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.