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Quality Investigator INT in Mesa, AZ at Volt

Date Posted: 11/10/2018

Job Snapshot

  • Employee Type:
  • Location:
    Mesa, AZ
  • Duration:
    48 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

Volt is seeking a quality engineer to respond to field inquiries received by phone, electronic or verbal correspondence and document reported complaints according to applicable SOP(s). This person will provide technical support and remote troubleshooting guidance as needed. Review associated records; provide technical guidance, and contact users and customers to collect information on the treatment, product performance, and functionality. Conduct periodic follow-up to close complaints in a timely manner. Complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure. 
Support statistical analysis of complaint trends. Recommend and implement operational changes to improve efficiencies in all aspects of complaint handling. Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.  Additional responsibilities may include submitting MDRs and Vigilance Reports according to regulatory timelines. Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting. Bachelor's Degree required, Bachelor of Science or Engineering Preferred. Medical Device experience preferred

Volt is an equal opportunity employer.