Careers

Quality Assurance Specialist - CAPA's, Complaints, MDR's, Removals

As a member of the Quality and Regulatory group, the Quality Assurance Specialist will work to ensure compliance with FDA and international regulations and will participate in the ongoing improvement and maintenance of SpineFrontier's Quality Management System. The successful candidate will contribute to risk compliance efforts across the organization, assist with corrective and preventive actions, and support complaint handling. This is an opportunity for a quality professional to apply their knowledge and clearly see the benefits realized from their individual contribution.

Essential Duties and Responsibilities

Primary
To contribute to corrective and preventive actions and complaint handling processes throughout the organization including MDRs, Advisory Notices, Removals and Recalls, as applicable. A successful candidate will be able to perform root-cause analyses, facilitate and oversee the implementation of corrective actions, and verify effectiveness of corrective actions.

Secondary
Other responsibilities may include, but are not limited to:

  • Support post market surveillance (PMS) and risk management efforts
  • Work with internal teams and vendors to resolve disposition of non-conforming material
  • Support incoming, in process, and final acceptance activities
  • Perform internal quality system audits
  • Provide quality input to product development teams

Qualification

    Required
    • 1-3 years in quality role in medical devices or bio/pharma
    • Bachelor's degree (preferred) or the equivalent experience and training
    • Excellent problem solving skills
      • Must be able to define problems, collect data, establish facts, and draw conclusions
    • Excellent writing, communication, and presentation skills
    • Working knowledge of:
      • 21 CFR 820 QSR, ISO 13485, ISO 14971, GMP
      • MAUDE Database
      • CAPAs/Complaints
    • Successful history of developing and maintaining controlled procedures and manuals
    • Ability to work in an extremely fast-paced, dynamic environment:
      • Constructively and collaboratively with cross functional team members
    • Excellent organization and communication skills, motivated, and self-starter
    • Proficient in Microsoft Office Suite
    Preferred
    • Quality auditing experience
    • Proficiency in statistics
    • Legally authorized to work in the United States on a regular full-time basis without restrictions

    Working Conditions

    Work is generally performed within an office environment, with standard office equipment available. Travel up to 15%

    Physical requirement

    Must be able to read, write and communicate fluently in English.

    We offer tremendous room for advancement and income potential. All submissions will be held in the strictest confidence. This position is being sought after for immediate hire. The company is an Equal Opportunity Employer. Please submit your resume and cover letter to.Please submit your resume and cover letter to mycareer@spinefrontier.com