Xtant Medical

Quality Engineer

Title: Quality Engineer
Status: Full-Time, Exempt
Location: Belgrade, MT

Summary:

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.

Position Summary

This position is responsible for ensuring ongoing supplier performance and management for all hardware products. This person will support the activities of the Director of Quality Assurance and Regulatory Affairs.

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 803, 806, 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 (CMDR), as applicable, and adhere to all other applicable standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice.
  • Remain accountable for and ensure the quality of critical medical device and human tissue supply chain from raw material to delivery of finished product.
  • Trending and statistical analysis to create presentation-ready data for Management Review.
  • Manage the selection and qualification of new critical Suppliers.
  • Perform periodic off-site quality audits of new and active Suppliers per Xtant Medical’s Quality Management System (QMS).
  • Actively and professionally communicate with Suppliers.
  • Identify and address areas within the company to improve product quality.
  • Support the quality functions of Quality Assurance, Regulatory Affairs, and all other departments.
  • Other Projects and Initiatives as assigned.

 

Knowledge/Skills Required

  • General knowledge of ISO 13485 and FDA Quality System Regulation guidelines required, advanced knowledge preferred.
  • Regulatory and Quality auditing training and experience preferred.
  • High level of proficiency in Microsoft Office Suite of software applications.
  • High level of attention to detail and accuracy.
  • Strong organizational skills and ability to prioritize tasks.
  • Exceptional documentation and technical writing skills.
  • Excellent verbal and written English language skills.
  • Ability to establish and maintain strong, effective working relationships with internal and external customers.
  • Ability to react quickly and adapt to changes in priorities, circumstances and direction.
  • Must be able to reason independently and work with minimum supervision.
  • Ability to interpret data and make sound judgments based on those interpretations.
  • Must be able to adapt to quickly changing priorities and schedules.
  • Ability to maintain good working relationships with all co-workers and outside contracts.
  • Must possess mobility to work in a standard office setting, to use standard office equipment, and to attend meetings at various sites within and away from the office.

Education

  • Bachelor’s degree in biology-related, engineering or an equivalent course of study.
  • 5+ years’ experience in medical device, biologics, orthopedic or health industry quality assurance.
  • Corrective/preventive action, root cause analysis, effectiveness check, statistical application experience and training.
  • Six-sigma black-belt certification preferred.

 

Working Conditions

  • Working conditions are normal for an office environment. standard office hours are Monday – Friday, 8:00am – 5:00pm.
  • Up to 50% travel required.

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.