Job Posting for Document Control/Quality Analyst
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/Quality Analyst that will support the company mission to market regenerative medicine products and medical devices. The Document Control/Quality Analyst will devote ~ 50% worktime ensuring ongoing maintenance and control of the company’s Quality Management System’s controlled documents and records. The Document Control/Quality Analyst will devote ~ 50% worktime performing Quality Assurance functions and support.
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 11, 820, 1270 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) Standard 13485; European Medical Device Regulation (MDR); Canadian Medical Device Regulations (CMDR), and any other standards and/or regulations as are applicable, and adhere to the standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice.
• Ensure ongoing review and knowledge of FDA, AATB and ISO standards and regulations. To maintain awareness of changes to these standards and ensure changes and revisions are addressed accordingly within Xtant Medical’s Quality Management System (QMS) Document Control and Record Control systems.
• Develop and maintain an understanding of Xtant Medical products and general biological 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 allografts as applicable.
• Help to accomplish quality objectives and develop quality standards, including Xtant Medical’s mission to design, manufacture and distribute innovative, safe, reliable and cost-effective solutions for the medical needs of patients.
• Adhere to Xtant Medical Standard Operating Procedures (SOPs) and safety protocols.
• Adhere to applicable laws, standards and regulations. Including but not limited to 21 CFR 820, 21 CFR 1271, ISO 13485, AATB, MDR, and SOR/98-282, and SOR/2007-118.
• Maintain a clean and safe working environment at all times. Represent the company in a professional manner to the public, customers and vendors. Maintain trusting relationships with physician partners, customers and fellow employees.
• Participate in activities related to CAPAs, Complaints, non-conformances, deviations, adverse outcomes and error reporting as requested by management.
• Perform trend analysis and produce appropriate trending reports as required for Management Review.
• Participate in and conduct Internal Audits.
• Help prepare for and participate in external audits with clients and/or government regulatory inspections (FDA inspectors, ISO inspectors, etc.).
• May be requested to provide/gather information pertaining to regulatory requirements of domestic and/or international agencies.
• Work with all departments and divisions within Xtant Medical to ensure understanding of and adherence to Xtant Medical’s Quality System.
• Legibly and accurately complete all documentation associated with assigned duties in accordance with current GDP and review the information of others as required.
• Write and revise Quality System documents as needed.
• 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.
• Support QA/RA Director and QA/RA Managers in any and all ways as needed.
• Ongoing development, validation, and maintenance of Xtant Medical’s Electronic Quality Management System (EQMS).
• Ongoing development and maintenance of Xtant Medical’s Quality Management System (QMS) 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.
• Ensure Xtant Medical’s Quality Management System (QMS) Document Control and Record Control systems are compliant with FDA 21 CFR11, 820, and 1271, AATB and ISO 13485, MDR, CMDR standards and regulations.
• 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.
• 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.
• Maintain document reference libraries and databases. This includes but is not limited to Document Control, Records, and External Standards.
• Assist in the timely and efficient completion and retention of documentation; including ensuring collection of approval signatures, writing document histories, activation of documents and distributing documents.
• Notification and read training distribution to all affected departments when document revisions and/or new documents are made effective.
• Generates New Hire Document Training Events for initial new hire training.
• Establishes and maintains training events including Annual SOP Reviews for all applicable staff.
• Performs and maintains Document Control Functions including but not limited to uploading documents, activating documents, retaining and maintaining traceability of documents and records, and document revisions, retaining individual document histories. Maintenance of Electronic Quality Management System, including all document control related functions.
• Responsible for off-site storage of documents and records including coordinating with the off-site storage facility to add additional archived file boxes to storage, preparation of documentation to ensure continued traceability for documents at off-site storage, request retrieval of documents or boxes from storage as needed.
• Ongoing maintenance of training records maintained in individual training files for all personnel of the QA/QC/RA.
• Responsible for the scanning, filing and archiving of training files for all technical staff resources no longer employed by the organization.
• Experience with document control and record maintenance required.
• 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.
• Ability to train, cross-train, direct and mentor others.
• Must be able to work independently and with minimal guidance.
• Must be able to adapt to quickly changing priorities and schedules.
• Must possess excellent organizational skills and strong attention to detail.
• Exceptional computer skills required with working knowledge of MS Word, Excel, Power Point, and other software as necessary.
• 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.
• Ability to investigate, interpret or analyze data and to draw sound judgements and conclusions.
• 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.
• Two (2) years of experience directly related to the duties and responsibilities listed above required.
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.