Customer First. Employee Direction. Building Strategic Value. Respect for Gift of Donation.
Why Xtant Medical?
JOIN A RISING organization that unites exceptional biologics with intuitive fixation design to inspire surgical solutions that advance regenerative medicine. Our vision is to be the leader in regenerative medicine by continuously elevating the standard of care. Xtant Medical’s mission is to develop, acquire, manufacture, and commercialize innovative, quality regenerative surgical products for the treatment of degenerative, traumatic, and deformity conditions for orthopedic and neurological applications.
Xtant Medical is looking for a qualified individual to join our team. This position is responsible to conduct routine inspection and testing of product quality from receiving inspection through final product release based on predetermined requirements. Activities include prioritization and completion of inspection/testing, as well as periodic documentation to support production and product release controls. Prior biomedical/fixation experience not required, but quality assurance or quality control experience and record control experience preferred.
Principle Duties & Responsibilities
- Adhere to all regulatory requirements and company policies
- Perform document reviews and record control tasks
- Perform inspections and analytical testing
- Assist in investigations and nonconformance’s
- Help prepare for and participate in external and internal audits
- This position may require contact with human tissue, blood, bone, and bodily fluids
- Author and/or review Standard Operating Procedures, Work Instructions and Forms
- Some travel may be required
- Demonstrate a commitment to patient safety, product quality and compliance with Xtant Medical’s quality manual and industry regulations
- Perform acceptance/rejection processes on components, subassemblies and finished products based on established product specification requirements
- Monitor and initiate corrective actions based on established action levels for environmental monitoring systems
- Participate in external and internal audits with regulatory bodies as needed
- Coordinate product disposition reviews and approvals
- Assure proper control, segregation, identification and status of materials
- Support Quality Engineering and Quality compliance as requested
- 3 years’ experience in medical device or technical industry is preferred
- Must be team-oriented and able to work well with others in a team setting
- Must be able to reason independently and work with minimal guidance
- Ability to interpret data and make sound judgments based on those interpretations
- Must have excellent attention to detail and organizational skills
- Prior experience with document and record retention preferred
- Knowledge of the FDA 1271 and 820, ISO 13485, and AATB preferred
- Must be able to adapt to quickly changing priorities and schedules
- Bachelor’s degree is preferred + 1 year minimum experience in QA functions and/or manufacturing, preferably in FDA-regulated industry, or equivalent experience is required
- ERP and automated document control experience is desired
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.