Dohmen Life Science Services

  • Complaint Coordinator, Medical Device

    Job Locations US-CA-Emeryville
    Job ID
    2018-2100
    # of Openings
    1
    Category
    Safety Operations
  • Overview

    At Dohmen Life Science Services, we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement.  Our behavior is guided by five simple values that define how we work and are the essence of what makes us successful:

     

    Caring: We are empathetic and respectful.  We ask “How can I help you?”

    Committed: We are dedicated and persistent.  We ask “How can I make it happen?”

    Creative: We are inventive and imaginative. We ask “How can I do it better?”

    Collaborative: We are cooperative and share our knowledge. We ask “How can we achieve success?”

    Courageous: We’re willing to risk failure over inaction. We ask “How can I challenge myself?”

     

    THE POSITION:

    The most important aspect of the Complaint Handling Coordinator position is a quality system minded person with experience reviewing and processing regulatory complaint calls, making MDR determinations, then handling the documentation and communication with FDA with regard to the MDR and annual reporting requirements.  This employee will be trained specifically to process specifications that are provided by a variety of customers.

     

    POSITION SUCCESS FACTORS:

    • Strong communication skills
    • Excellent documentation skills
    • Demonstrates good written and verbal communication skills
    • Demonstrates independent working skills with the ability to focus
    • Demonstrates attention to detail skills

     

     

    Responsibilities

    ESSENTIAL FUNCTIONS:

    • Interaction with clients on all process specifications outlined by DLSS clients
    • Responsible for demonstrating ability to perform complaint handling
    • Responsible for collecting follow-up complaint information, review of device history records, and making MDR determinations
    • Responsible for making decisions on call categories while entering data to initiate the complaint process, to assign investigation roles, and to communicate metrics to clients as appropriate
    • Responsible for ensuring that the complaint file is closed, which includes maintaining a complaint history database and analyzing the database for trends.
    • Perform preliminary classification of complaints and elevate complaints that require additional review for reporting (e.g. Medical Device Reporting, Medical Device Vigilance or other event reporting for International bodies worldwide)
    • Ensure all potentially reportable complaints are escalated to appropriate levels of management
    • Submit reportable complaints to the client and relevant regulatory authority
    • Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close complaint
    • All other duties as assigned

     

    Responsibilities:

    • Management of complaint processing
    • Data entry and data entry review of complaints in complaints database

    Qualifications

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

    The requirements listed below are representative of the knowledge, skill and/or ability required.

    • High school diploma with a 2-year associate's degree (in Science related field) is required; this education must be coupled with a minimum of three years of regulatory and/or quality systems experience. College degree strongly preferred.
    • A 4-year college degree with life sciences major coupled with a minimum of two years of experience is preferred for this position.
    • Careful attention to detail and an understanding that accuracy and precision in all aspects of work are necessary to be considered for this position.
    • Must be quality oriented and demonstrate consistent attention to detail.
    • Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required.
    • Proficiency with standard desktop software (Word, Excel, Outlook).
    • Experience with Access, Oracle, or other relational databases.
    • Experience with safety database systems and applications.  

    Personal Skills/Attributes/Qualifications

    • Positive Attitude and Energy – Exhibits an upbeat attitude, a genuine interest in others and a sense of humor. Energizes others and heightens morale through her/his attitude.
    • Communication Skills – Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate.
    • Innovator – Transforms creative ideas into original solutions that positively impact the company’s performance.
    • Highly Principled – Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior.  

    Working conditions

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

     

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