To apply for this position, please visit our company Careers Page at https://xtantmedical.com/careers/
Location: Belgrade, MT
Why Xtant Medical?
JOIN A RISING organization that is focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal fixation systems. Xtant Medical’s mission is to provide cost-effective technology and services that help clinicians efficiently perform their job.
This position will oversee the activities related to picking, packaging, and shipping finished goods product orders to customers to maintain Xtant Medical’s Quality and Compliance policies, as assigned. This person does not supervise others and will support the activities of the distribution manager, distribution supervisor, and distribution team lead(s).
Principle 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, fulfillment, and distribution systems utilized within the department including product descriptions and SKU’s. 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.
- Maintain required information in appropriate databases including allocating inventory to customers upon order processing.
- Operates FedEx shipment manager software to generate labels and documents.
- Track Material with Limited Shelf Life or Expiration Dates to appropriately discard inventory if within expiration window
- Employee shift schedules may vary depending on the needs of the department and high peak order times.
- Receive and store processed tissue when it is released to finished goods. Ensure finished goods are stored by product code, donor number, and expiration date.
- Use the First In First Out (FIFO) method when selecting inventory.
- Ensure all processed tissue deemed unacceptable is quarantined in such a manner that distinguishes it from distributable inventory.
- Receive, inspect, and store shipping supplies according to all SOPs. Ensure the shipping supply storage is maintained in an orderly fashion at all times.
- Maintain Excel spreadsheet of frozen grafts physical locations.
- Navigate FedEx Shipping Manager.
- Pull, process, and package customer orders.
- Communicate with Customer Service and other departments as necessary.
- Receive Tissue/Device releases into finished goods.
- Review and inspect tissue and complete corresponding paperwork for final release into distributable inventory.
- Assist in quarterly inventory audits and reconciliation.
- Any other duties as assigned.
- Effective communication skills, oral and written.
- Attention to detail.
- Strong organizational and time management skills.
- High School diploma, or equivalent.
- Prior job experience with relative job duties is preferred, but not required.
- Some knowledge of FDA, ISO, and AATB requirements as applicable.
- Ability to multitask.
- Stay calm under pressure and ability to work quickly, as needed.
- Proficient computer skills required such as advanced knowledge of Microsoft Office and other software as necessary
- Ability to investigate and analyze information and to draw conclusions.
- Prior shipping experience with FedEx Ship Manager software preferred.
Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages
No H1B Sponsorships Available for this Position
Xtant Medical is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors.