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 Supervisor – Sets Management that will support the company mission to market regenerative medicine products and medical devices. This position will oversee activities related to inventory fulfillment, quality maintenance, and regulatory compliance in their department, as assigned. This position will assist in daily operations related to their respective department as required to meet goals.
This position works with the department leader and with other management and analysts at the operations 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.
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’s 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, as applicable.
- Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures.
- Implement and maintain all procedures and safety protocols to withhold a safe and productive work environment.
- Support Xtant Medical’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients.
- Represent the Company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees.
- Manage a team of Set Technicians to perform daily decontamination, inspection and restocking of sets
- Cross department communication liaison.
- This position will maintain inventory functions which may include daily cycle count program, daily ERP transactions, and supporting required reports as needed.
- Uphold metrics reflective of department goals set by management.
- Ensure all departmental processes, work instructions, SOPs are being followed.
- Ensure accuracy of decontamination, inspection and restocking of all sets.
- Assist Hardware Operations Manager in efficient utilization of sets and availability.
- Maintain and execute product launches, set builds, and set decommissions.
- Manage incomplete sets and coordinate fulfillment needs through appropriate channels for return to service.
- Implement and maintain training plans and qualification trainings.
- Covering for Hardware Operations manager during absence.
- Any other duties assigned by manager.
- Proven ability to read, write, review, and complete forms.
- Prior experience implementing and training new software to a team of individuals required.
- Prior experience with ERP support software preferred.
- Demonstrated ability to communicate effectively both orally and in writing.
- Excellent time management skills required.
- Must possess excellent organizational skills and strong attention to detail.
- Advanced computer skills required such as ability to effectively utilize MS Word, Excel, PowerPoint, Outlook, Adobe and other software as necessary.
- Ability to make strategic decisions under pressure to support company goals.
- Ability to investigate and analyze information and to draw conclusions.
- Prior experience with records maintenance and document control required.
- Ability to implement and train individuals on assist programs
- Must be able to reason independently and work with minimal 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, judgment, 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 judgment in recognizing scope and authority.
- Must be able to communicate well and train others in complex and detailed business contracts.
- Must be able to uphold team morale while still administering strict guidelines.
- Must possess mobility to work in a standard office setting and to use standard office equipment and to attend meetings at various sites within and away from the office.
- 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.
- Must be able to lift, push, and pull 80 lbs.
- College level or equivalent is preferred.
- Three (3) to five (5) years’ industry experience is required.
- Three (3) to five (5) years’ inventory experience.
- Prior leadership experience is required.
- Advanced Microsoft Suite experience.
- Basic knowledge of ISO 13485 Medical Devices – Quality Management System and FDA 21 CRF Part 820 Quality System Regulation.
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.