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.
Xtant Medical is seeking a talented and dedicated Document Control/Training Specialist that will support the company mission to market regenerative medicine products and medical devices. This position will contribute to the maintenance and management of an effective Quality Management System within the Quality Assurance/Regulatory Affairs (QA/RA) department. This position ensures ongoing maintenance and control of the company’s Document/Record Control System and Training System. This position interacts with employees throughout the company, with other divisions of the company and with external contacts.
Principle Duties & Responsibilities
- Develop and maintain an understanding of the requirements of the applicable standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP, ISO 13485, MDD, and CMDR. Adhere to and promote compliance to the applicable standards and regulations throughout the company.
- 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.
- Adhere to Xtant Medical Standard Operating Procedures (SOPs) and safety protocols.
- Support Xtant Medical’s 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 Medical SOPs.
- Develop and maintain an understanding of how the Document Control system interacts with all activities performed by the various departments of the company. Understand how the flow of document revisions affects the departments and their ability to function.
- Manage timely and efficient completion and retention of documentation, including but not limited to activation, obsoletion, and distribution of documents when applicable.
- Ongoing development and maintenance of Xtant Medical’s Document Control and Record Control systems to meet the needs of the company and ensuring the integrity of the systems both in hard copy (paper) and electronic formats.
- Responsible for ongoing review and improvement of the Document Control system and Record Control system to ensure continued compliance with company procedures and regulatory standards. Write and revise Quality System documents as needed.
- Help prepare for and participate in external audits with clients and/or government regulatory inspections (FDA inspectors, ISO assessors, etc.) as requested by QA/RA Management.
- Participate in projects where changes to documents, may be required, as part of changes to, improvements to and/or the launch of new products and processes.
- Maintain document reference libraries and databases. This includes but is not limited to Document Control, Records, and External Standards.
- Responsible for managing on-site and off-site storage of documents and records.
- Ongoing development and management of Xtant Medical’s Training System.
- Ongoing maintenance of training records maintained in individual training files.
- Responsible for the scanning, filing and archiving of training files for all technical staff resources no longer employed by the organization.
- May conduct and/or participate in internal audits.
- Support QA/RA Director and QA/RA Managers in any and all ways as needed.
- Experience with document control and record maintenance preferred.
- Experience with eQMS implementation and maintenance preferred.
- Knowledge of FDA, ISO and AATB requirements preferred.
- Ability to write, review and edit documents and records.
- Ability to communicate effectively both orally and in writing and the ability to present effectively to groups.
- Exceptional computer skills required with working knowledge of MS Word, Excel, Power Point, and other software as necessary.
- Ability to investigate, interpret or analyze data and to draw sound judgements and conclusions.
- Must possess excellent organizational skills and strong attention to detail.
- BA/BS degree from an accredited college or university is preferred. High School Diploma or General Education degree required; with equivalent job-related work experience.
- One (1) to two (2) years of experience directly related to the duties and responsibilities listed above preferred.
- Ability to train, and cross-train others.
- Must be able to work independently and with minimal guidance.
- Must be able to adapt to quickly changing priorities and schedules.
- Interpersonal skills and the ability to effectively communicate with a wide range of individuals including co-workers, vendors and representatives from regulatory agencies as necessary.
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.