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Quality Operations Specialist

The Fountain Group

Quality Operations Specialist

Irvine, CA
Full Time
Paid
  • Responsibilities

    Job Description

    Hello,

    My name is Sydney, and I am a Recruiter with THE FOUNTAIN GROUP.  We are a national staffing firm and are currently seeking a ­­­­­­­­QUALITY OPERATIONS SPECIALIST (MEDICAL DEVICE COMPLAINTS) for a prominent client of ours.  This position is located in ­­IRVINE, CA. Details for the position are as follows:

    JOB DESCRIPTION:

    •                    Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines. 

    •                    Supports quality functions pertaining to manufacturing line support and maintenance, including SAP

    •                    Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation

    •                    Assist complaint intake group through review and verification of initial complaint coding.

    •                    Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections. Ensure that appropriate corrective actions are implemented to address the root cause of trending issues.

    QUALIFICATIONS:

    • Experience with quality / regulatory reporting for medical devices (e.g. MDRs, MDV, MDD, Vigilance reports, medical device complaint files and records, etc.) 
    • Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485
    • Proficiency in MS Excel
    • Exp w/ clinical customer complaints for medical devices preferred
    • PMA – Pre market Authorizations preferred
    • 510K preferred
    • Coding medical device complaints preferred
    • SAP preferred

    If you are interested in hearing more about the position please respond to this posting with your resume attached.

    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