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Quality Operations Specialist (Medical Device Complaints)

The Fountain Group

Quality Operations Specialist (Medical Device Complaints)

Irvine, CA
Full Time
Paid
  • Responsibilities

    Job Description

     

    JOB DESCRIPTION

    • Investigate assigned technical and clinical customer complaints and perform technical investigations and document results in accordance with established procedures and timelines.

    QUALIFICATIONS

    • Experience with regulatory reporting for medical devices (e.g. medical device complaint files and records, MDRs, MDVs, MDDs, Vigilance reports, etc.)
    • Knowledgeable of FDA regulations including 21 CFR parts 820, 803, and ISO 13485.
    • Experience with Microsoft Excel.
    • Experience with clinical customer complaints for medical devices, PMAs, 510Ks, coding device complains, and SAP are preferred.

    If you are interested in hearing more about the position, PLEASE RESPOND TO THIS POSTING WITH YOUR RESUME ATTACHED.

    You may also forward this posting to any qualified friends or colleagues as we do offer a REFERRAL BONUS for any candidate who is hired and still gainfully employed after 30 days.

    Company Description

    Looking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field