Xtant Medical

Supplier Quality Engineer

Title: Supplier Quality Engineer
Status: Full-Time, Exempt
Director of Regulatory Affairs and Quality Assurance
Location: Belgrade, MT

Summary:

No H1B Sponsorships Available for this Position

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.

Position Summary

Xtant Medical is seeking a talented and dedicated Supplier Quality Engineer that will support the company mission to market regenerative medicine products and medical devices.  This position will support the activities of the Director of Regulatory Affairs and Quality Assurance and will interact with employees in the Department.  The Supplier Quality Engineer may also interact with other Department Managers, Supervisors, and employees. This position helps ensure that Xtant Medical complies with and meets the standards of the FDA, AATB, ISO 13485, and other regulatory agencies as necessary.

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.
  • Work with all departments and divisions within Xtant Medical to ensure understanding of and adherence to Xtant Medical’s Quality System.
  • Manage Supplier Qualification activities, including but not limited to, initial qualification, re-qualification, SCAR issuance, supplier qualification termination, etc.
  • Plan and conduct regular audits with suppliers including onsite qualification of product and processes. Write audit reports to disclose findings, Present findings as needed.  Maintain and update critical supplier audit system and schedule.
  • Support new supplier evaluation and qualification including inspection and first articles.
  • Measure, analyze, and improve supplier performance and reduce supplier nonconformances.
  • Work to resolve supplier technical issues in a timely manner to ensure continuity of supply.
  • Conduct receiving inspections, in-process inspections and finished device inspections.
  • Inspecting and monitoring receiving, in-process, and final product control results including collection and testing of representative samples.
  • Participate in and help lead successful external audits (FDA, ISO, etc.). Serve as a liaison between the Director of RA/QA and the auditor(s) during regulatory inspections.
  • Perform and participate in validations as needed.
  • Participate in design control as needed.
  • Help to accomplish quality objectives and develop quality standards.
  • Participate in Complaint, Deviation, Nonconformance, and CAPA investigations as necessary.
  • Support QA/RA Management in any and all ways as needed.
  • Other duties as assigned by direct supervisor

Education/Knowledge/Skills Required

  • Bachelor’s degree in biology-related, engineering or an equivalent course of study is required.
  • 5+ years’ experience in medical device, biologics, orthopedic or health industry quality assurance is preferred.
  • Corrective/preventive action, root cause analysis, effectiveness check, statistical application experience and training is required.
  • Six-sigma black-belt certification preferred.
  • General knowledge of ISO 13485 and FDA Quality System Regulation guidelines required, advanced knowledge is preferred.
  • Regulatory and Quality auditing training and experience is preferred.
  • High level of proficiency in Microsoft Office Suite of software applications is required.
  • High level of attention to detail and accuracy is required.
  • Strong organizational skills and ability to prioritize tasks is required.
  • Exceptional documentation and technical writing skills is required.
  • Excellent verbal and written English language skills is required.
  • Ability to establish and maintain strong, effective working relationships with internal employees and external customers is required.
  • Ability to react quickly and adapt to changes in priorities, circumstances and direction is required.
  • Must be able to reason independently and work with minimum supervision.
  • Ability to interpret data and make sound judgments based on those interpretations is required.
  • Must be able to adapt to quickly changing priorities and schedules.
  • Ability to maintain good working relationships with all co-workers and outside contracts is required.
  • 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.

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.