Classification: Full Time - Non-exempt

Reports to: Medical Device Technician Team Lead

Job SummaryThis position will perform activities related to inventory fulfillment, quality maintenance, and regulatory compliance in their department, as assigned. This person will support the activities of the Medical Device Technician Team Lead and/or Manager.

This position works with the department team lead and manager and with other technicians at the fulfillment and distribution level to help ensure that Xtant Medical complies with and meets the standards of the Food and Drug Administration (FDA) and International Organization of Standardization (ISO), and other regulatory agencies as necessary in distributing Xtant Medical inventory.

Supervisory Responsibilities

This position does not supervise others or teams

Duties and Responsibilities

Develop and maintain an understanding of relevant industry standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485, ensuring compliance with these requirements across the organization.

Actively contribute to the fulfillment of Xtant Medical’s mission, values and quality policy

Maintain a safe, clean work environment and ensure proper disposal of hazardous and non-hazardous waste according to OSHA guidelines and Xtant Medical standard operating procedures (SOP)

Develop and maintain an understanding of Xtant Medical products

Understand the interaction of departmental activities with the Quality System and their impact on the production of medical devices and human cells, tissues, and cellular and tissue-based products (HCT/Ps)

Adhere to Xtant Medical SOPs, Good Documentation Practices (GDP), and safety protocols

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 and cleaning

Daily Product Transaction Activities – inventory allocation within an ERP system, tracking and reconciling inventory returns to match finance and invoicing

Maintaining tray inspection throughput 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

Other duties as assigned

Financial Responsibilities

Submit timely expense reports and abide by the Expense Reimbursement Policy

Training

Complete required training, including but not limited to initial orientation and environmental health and safety training prior to performing tasks

Participate in training programs, ensuring timely completion and accurate, up-to-date training records

Complete annual SOP review and safety training (i.e. OSHA, bloodborne pathogens) as applicable

May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable

May be asked to travel to complete LIVE training and job shadowing

Document Control and Record Control

Complete all documentation accurately and legibly per GDP, retain records according to Xtant Medical’s procedures, and review others’ documentation as needed

Performance of Duties

Perform duties and responsibilities to the highest standards with efficiency, professionalism, and attention to detail; adapt to job changes and contribute to team success

Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees

Maintain confidentiality of donor and recipient information according to HIPAA

Required Skills/Abilities

Must be able to reason independently and work with guidance

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

Ability to interpret data and make sound judgments based on those interpretations

Must be able to adapt to quickly changing priorities and schedules

Must have excellent manual dexterity and good eye/hand/foot coordination

Education & Experience

High School Diploma or equivalent is required

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

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

This position is based in an office environment

Standard work hours are Monday – Friday; 8:00 am – 5:00 pm, with occasional overtime or weekend work based on project/production needs. Shift times may change based on the current needs of the department

This position is located at 732 Cruiser Lane – Belgrade, MT

Will operate magnification and inspection/laboratory equipment

Duties may include contact with human tissue, blood, bone, and fluids (Clinical Laboratory, Donor Services, Engineering, Processing, Packaging and Labeling, etc.). Working in PPE such as cleanroom suites, with face shields and masks as necessary

Adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products

This position will sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, gloves, etc.

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

Physical Requirements

Ability to sit, stand, and work at a computer for prolonged periods

Ability to lift, carry, push or pull items of varying weight, typically up to 80 lbs.

Ability to move, bend, or twist the body in various ways

Ability to perform repetitive motions, such as reaching, grasping, bending, squatting, and stooping

Requires hand-eye coordination and manual dexterity for tasks such as typing, using hand tools or equipment, and assembling or handling small components with precision

Ability to see clearly, whether with or without corrective lenses

Ability to hear and understand safety signals, alarms, and requests in a noisy environment

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.

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.