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.
Xtant Medical is seeking a talented and dedicated Sterilization Team Lead that will support the company mission to market regenerative medicine products and medical devices. This position will perform and oversee support activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. This person directly oversees the activities of the Sterilization Team and will support the activities and goals of the department supervisor or manager. This position interacts with employees in the Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.
This position reports to the Processing Support Supervisor. This position may provide additional support to other team leads, supervisors, or departments as requested. This position supervises other Sterilization team members.
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 for Standardization (ISO) 13485, European Medical Device Directives (MDD), Canadian Medical Device Regulations, Occupational Safety and Health Administration (OSHA), and other regulatory standards as applicable.
- Adhere to all Xtant Standard Operating Procedures (SOPs) and safety protocols while operating in compliance with regulatory standards.
- Develop and maintain an understanding of Xtant products and general biological and chemical systems utilized within the Processing Department. Know how the activities performed in the Processing Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable.
- Support the Xtant mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients.
- 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 SOPs.
- Responsible for participating in and overseeing the decontamination, disinfection, cleaning, and sterilization (where appropriate) of all non-disposable processing instruments and equipment.
- Manually wash processing instruments and equipment according to Xtant SOPs.
- Ensure all reusable tissue processing equipment and instruments are suitable for use, including inspection and assembly if applicable.
- Prepare relevant donor processing documentation, labels, and other consumable supplies for sterilization.
- Aseptically introduce equipment and supplies into the cleanroom environment.
- Safely operate, monitor, and maintain cleaning and sterilization equipment in accordance with manufacturer recommendations and equipment-specific SOPs when applicable.
- Safely prepare and handle cleaning reagents and solutions according to MSDS/SDS and SOPs and follow OSHA bloodborne pathogen standards, Universal Precautions, and current Good Tissue Practices (cGTP) when handling biological material.
- Provide facility cleaning support to areas outside of the cleanroom environment.
- Collect and prepare soiled cleanroom garments for shipment to vendor.
- Collect and prepare solid biohazardous waste for shipment in accordance with OSHA standards and Xtant SOPs.
- Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue.
- Assist with error and nonconformance investigation and resolution within the Quality System. Provide support for developing corrective and preventative actions (CAPAs) as necessary.
- Must maintain confidentiality of donor and recipient information.
- Provide assistance and support to other teams, departments, team leads, and supervisors as requested.
- Ability to interpret data and make sound, independent judgments based on those interpretations.
- Demonstrated ability to identify, address, and resolve production-related issues and identify ways to prevent reoccurrence.
- Mechanical aptitude or an understanding of simple mechanical systems is advantageous.
- Must be able to compose oneself in a professional and courteous manner in all aspects of interaction with fellow employees and use good judgment in recognizing scope and authority.
- Must have good working knowledge of applicable FDA, ISO, and AATB regulations.
- Must demonstrate proficiency in aseptic techniques and practices.
- Demonstrate capability to communicate effectively both orally and in writing.
- Ability to identify safety risks and manage appropriately.
- Must be able to adapt to quickly changing priorities and schedules.
- Must possess excellent organizational skills and impeccable attention to detail.
- Must be able to reason independently and work with minimal guidance.
- Basic computer skills are required, such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary.
- Experience with record maintenance and document control required.
- High School Diploma or equivalent required. Associates degree or two-year certificate preferred.
- Minimum of two (2) years of experience in biologics production support and/or medical sterilization environments is required.
- Must have or be willing to acquire Certified Tissue Bank Specialist (CTBS) certification.
- Some familiarity with basic laboratory techniques and equipment is desired.
- At least one (1) year in a senior technician or leadership role is preferred.
- Experience or demonstrated ability to lead, organize, and direct the activities of other team members to achieve successful outcomes.
- Ability to train, cross train, direct, and mentor others.
Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages
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.