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 Supply Chain Coordinator I to join our team on-site in Belgrade, MT. It offers a pay rate of $$22.50-$24.00/hour DOE 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!

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
• And more...

Responsibilities of the Supply Chain Coordinator I

This position supports production, product design, development, quality, and regulatory compliance activities, working with department leadership and technicians to ensure Xtant Medical meets regulatory standards.

This role does not involve supervision of others.

• 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 Directive (MDD) and Canadian Medical Device and Tissue Regulations, as applicable, and adhere to standards and regulations
• 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 and regulations
• Develop and maintain an understanding of the 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
• 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
• 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
• Follow OSHA Blood Bourne Pathogen Standards, Universal Precautions, AATB Standards, and current Good Manufacturing Practices (cGMP), and current Good Tissue Practices (cGTP) during all phases of packaging and labeling, storage, irradiating supplies, and cleaning
• Clean, maintain, and operate instruments and equipment as needed
• Generate and manage work orders according to current inventory usage to ensure an adequate inventory of irradiated supply packs
• Assess and manage raw supply inventory levels based on current and past production demands, and effectively communicate supply needs to the Purchasing team
• Calculate quantities needed based on current inventory usage
• Receive supply orders into warehouse and ERP software
• Efficiently prepare and assemble supply packs for shipment to a third -party sterilization facility
• Familiarize with the procedures for assigning expiration dates to raw and irradiated supplies and authorizing their use in production
• Perform Quality Control (QC) functions of examining and inspecting supplies to ensure the configuration is correct and undamaged following the SOPs
• Demonstrate accuracy in stocking inventory in designated locations and conduct thorough inspections to ensure items are undamaged
• Other duties as assigned

Education/Credentials, Experience & Training

• High School Diploma or equivalent. Two to four years college preferred
• Knowledge of aseptic techniques
• Prior experience with document control and record retention is preferred
• Proficient in Microsoft applications (Word, Excel, Access, Outlook, etc.) for basic reporting tasks
• Capable of operating equipment such as sealers and weight scales, as well as common office tools like copiers
• Ability to work independently with little supervision, delivering optimal results to achieve company goals
• Excellent organization skills with a keen attention to detail
• Strong analytical and investigative abilities to assess information and draw conclusions
• Effective verbal and written communication skills
• Easily adapt to quickly changing priorities and schedules

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 deal effectively with a wide variety of personalities and situations requiring tact, judgement, 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 judgement in recognizing scope and authority
• Must be able to perform repetitive tasks/motions
• Must be able to lift, push, and pull 60 lbs
• Must have excellent manual dexterity and good eye/hand/foot coordination

Working Conditions

• This position is based in an office, environmentally controlled area (ECA), and warehouse environment

• Standard work hours are Monday – Friday; 8:00 am – 5:00 pm, with occasional overtime or weekend work based on project/production needs

• Work may require long periods of sitting, standing, and working at a computer
• Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
• 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
• May work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels
• Shift times may change based on the current needs of the department

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
• This position will sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves, etc
• Will require experience or training in the routine handling of chemicals and biohazards
• 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 60 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.