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 Quality Assurance Analyst 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 QA/RA department. This position ensures that Xtant complies with and meets the standards of the FDA, AATB, ISO and other regulatory agencies as necessary.
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); 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 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 the Xtant 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.
- Execute and/or contribute to investigations of Corrective Action / Preventive Action, Nonconformances, etc.
- Support Xtant’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients.
- Complete annual SOP review and OSHA safety training as applicable.
- 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.
- Complete performance reviews and performance correction notices if applicable.
- Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees.
- Work with all departments and divisions within Xtant to ensure adherence to Xtant’s Quality Management System.
- Perform and participate in process validations.
- Participate in design control.
- Help to accomplish quality objectives and develop quality standards.
- Inspecting and monitoring receiving, in-process, and final product control results including collection and testing of representative samples.
- Perform internal audits. Write audit reports to disclose findings. Present findings as needed.
- Perform final review of processing records DHRs.
- Develop and perform process validation studies.
- Support QA/QC Director and QMS in all activities.
- 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 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.
- Bachelor’s degree from an accredited college or university relating to the specific department.
- Minimum of three (3) years’ experience that is directly related to the duties and responsibilities specified.
- CAPA, Complaint and Nonconformance experience preferred.
- Knowledge and experience in biologics/medical device manufacturing or other relevant cleanroom/aseptic environments.
- Knowledge of laboratory techniques, aseptic technique, and use of various lab equipment preferred.
- Knowledge of FDA, ISO, and AATB regulations.
- Ability to write, review, and edit technical reports and SOPs.
- Experience in regulatory standards, regulatory inspection hosting, GLP, GMP and GDP.
- Must possess excellent organizational skills and strong attention to detail.
- Track record of effective problem solving
- Proficient computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary.
- Ability to communicate effectively both orally and in writing and the ability to present effectively to small and large groups.
- Ability to assist in the development and presentation of educational programs and/or workshops.
- Ability to investigate and analyze information and to draw conclusions.
- Ability to travel as company representative.
- Experience with records maintenance and document control.
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.