• Field Assurance Associate

    Posted Date 2 weeks ago(1/4/2019 11:30 AM)
    Job ID
    2019-2096
    Job Location
    US-GA-Kennesaw
    # of Openings
    2
    Category
    Quality Assurance
  • Introduction

    Is This The Role For You?

     

    We hire smart people with big hearts.  People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.

     

    If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

    Position Overview

    Under the direction of the Manager, Field Assurance, and with minimal supervision, will assist with maintaining the Field Assurance Program to ensure compliance to all safety, regulatory and corporate requirements.  Ensure compliance to all U.S. and International regulations regarding the handling and timely reporting of Customer/Product Complaints and Adverse Events for tissue and medical device. Ensure that areas identified as “Principle Responsibilities” are accomplished in an efficient and professional manner.   

     

    Responsibilities

    Complaint Handling

    • Evaluate all reported events according to Field Assurance procedures.
    • Process complaints through electronic complaint handling system and effectively manage timelines of each assigned complaint.
    • Perform administrative tasks and facilitate/perform sample evaluations associated with complaint investigations and documentation to ensure complaints are accurate, comprehensive and completed in a timely manner.
    • Coordinate and lead multidisciplinary teams during in-depth investigations of Adverse Events and/or Customer Complaint.
    • Perform final review of the investigational reports for accuracy, root cause analysis and identification of potential Corrective Actions/Preventive Actions (CAPAs).
    • Interact with Healthcare workers and CryoLife employees regarding customer complaints and adverse events.
    • Provide guidance and education regarding Customer Complaint processing, Medical Device Reports, complaint reportability, complaint scenarios, sample return procedures and regulatory compliance.
    • Maintain the Field Assurance Complaint Laboratory, including but not limited to routine cleaning, stocking supplies and equipment repair requests.

     Regulatory Reporting

    • Exhibit thorough understanding of regulatory reporting requirements for tissue and medical device.
    • Ensure regulatory reporting is in a compliance with all applicable local, state, federal and international requirements for Complaint Handling and Adverse Event reporting.
    • Submit and track regulatory reports in a timely manner.

     

    Note: Management retains the discretion to add or change the duties of this position at any time to support current business needs

     

     

    Qualifications

     

    • Four year college or university program certificate, preferably in life sciences discipline and 2-4 years in regulated industry with related experience such as handling complaints investigations, root cause analysis and identification of corrective actions, understanding of regulatory reporting requirements for tissue and medical device, managing MDRs/Vigilance; or equivalent combination of education and experience.
    • Must be able to maintain a high energy level and be able to prioritize, manage and follow up on numerous projects.
    • Effective communication skills, both oral and written, ability to communicate and interface with people at all levels.
    • Must be detailed orientated and exhibit a high degree of flexibility and initiative.
    • Must have personnel computer skills, i.e. word processing, excel spreadsheets.

    Company Info

    Who We Are.

    CryoLife is one of the world’s contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company’s inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide.

     

    CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta.

     

    CryoLife is an Equal Opportunity/Affirmative Action employer.

    CryoLife provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

     

    Reasonable Accommodations
    CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.

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