Reports To: Medical Device Technician Team Lead

A. Purpose and Scope of Position

This position will perform activities related to inventory fulfillment, quality maintenance, and regulatory compliance in their department, as assigned. This person does not supervise others but 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.

B. Organizational Relationship

This position reports to the Medical Device Technician Team Lead and/or Manager. This position may provide additional support to other team leads, supervisors, or departments as requested.

C. Duties and Responsibilities

1. Specific Job 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 biological and chemical 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
   • Complete annual SOP review and OSHA safety training
   • Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPs
   • 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:
     1. Allocate new inventory from warehouse to fill empty tray items
     2. Transfer items missing in tray to Distributor’s MIA warehouse for invoicing
     3. Update lot numbers in all trays to properly track inventory
     4. Complete all associated documentation and tray second checks before returning to finished goods shelf
     5. 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
2. Financial Responsibilities
   • Submit timely expense reports and abide by the Expense Reimbursement Policy
3. Training
   • Participate in training plans and programs and complete in a timely manner within set deadlines
   • Complete required training prior to attempting to perform a task
   • May be asked to travel to complete LIVE training and job shadowing
4. Management
   • This position does not supervise others
   • Work with and support the activities of distribution and fulfillment and other divisions as requested
5. Document Control and Record Control
   • Assist in the completion and retention of documentation pertaining to all SOPs as required
   • Legibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as required
   • Write and revise a variety of technical documents including contracts, non-disclosure agreements, SOPs, and training documents as needed and assigned
   • Maintain information in physical and electronic files as required
   • Train on and demonstrate proficiency in Xtant Medical’s document control system
6. Other duties as assigned

1. Performance of Duties
   • Complete required training prior to performing tasks, including initial orientation and environmental health and safety training
   • Perform all duties according to established procedures and follow appropriate safety precautions and measures
   • Conduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end users
   • Maintain a clean and safe working environment at all times
   • Must maintain confidentiality of donor and recipient information according to HIPAA

D. Job Requirements

1. Education/Credentials Experience & Training
   • 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
2. Technical Requirements/Skills
   • Some knowledge of FDA and ISO requirements as applicable

• Demonstrated capability to communicate effectively both orally and in writing
• Ability to multitask
• Must possess excellent organizational skills and strong attention to detail
• Basic computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
• Ability to investigate and analyze data to draw conclusions and drive solutions
• Experience with records maintenance and document control needed

3. Managerial Experience

• N/A

4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications

• Must be able to reason independently and work with guidance
• Ability to interpret data and make sound judgments based on those interpretations
• Must be able to adapt to quickly changing priorities and schedules
• Strong attention to detail with a drive for organization
• Able 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

5. 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
  

6. 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.

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.