Quality Affairs Specialist

The Quality Affairs Specialist is responsible for the support and continuous improvement of the Wenzel Spine and IsoStem Quality Systems. In addition, the Quality Affairs Specialist will support supplier management, operations, and product development projects. The Quality Affairs Specialist reports to the COO.

Job Type:

Full Time

Location:

Austin

Job Functions:

  • Day-to-day needs, maintenance, growth, and continuous improvement of the entire Quality System, including developing process maps, writing procedures, work instructions, and record management.
  • Complaint handling, Material Review Board, and CAPA administration.
  • Audits, including internal and supplier audits and Regulatory Inspections.
  • Continuous improvement and maintenance of the QCBD quality management software.
  • Training compliance for Wenzel Spine.
  • Preparation and delivery of Management Review Meetings.
  • Proactive solutions where opportunities for improvement have been identified.
  • Quality goals and objectives are achieved, including performing trend analysis.
  • Communicate needs, timelines, and resources effectively to COO
  • Required Qualifications:

    • Minimum of 2 years of experience working in and supporting an ISO 13485 and FDA compliant quality system, orthopedics or spine medical device preferred.
    • Strong computer skills, to include: Outlook, Excel, Power Point, Visio, and Word.
    • Strong work ethic, highly motivated self-starter, with excellent presentation and communication skills.
    • Ability to work on multiple projects and support multiple disciplines at any given time.

    Experience:

    2+ Years

    Education:

    High School Diploma, 4-year college degree (BS) preferred.

    License/Certification:

    Travel Required:

    yes