• CAPA Specialist

    Posted Date 2 weeks ago(10/1/2018 10:11 AM)
    Job ID
    2018-2040
    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

    To assist in providing assurance the Company operates in a manner that is substantially compliant with all required regulations and standards as determined by both internal and external assessments to the requirements of 21 CFR Parts 803, 806, 820, 1270, 1271, ISO 13485 and related AATB Standards. To assure the Corrective and Preventive Action Program, and Audit Programs requirements comply with all applicable requirements and to keep management advised of the status of these programs.  This position will also provide assurance that compliance issues are managed to an adequate resolution. 

    Responsibilities

    1.) Through internal and external audits, assess operations to assure compliance to all applicable regulations and standards.

     

    2.) Advise management of all significant audit findings, adverse events, or post market product issues within 24 hours of becoming aware of such information.

     

    3.) Assist with the review of any new or revised applicable regulatory requirements and implementation of any resulting upgrading of related written procedures.

     

    4.) Assist with the Company's written response process to address any alleged regulatory findings.

     

    5.)  Coordinate and monitor the Company's CAPA program to assure CAPAs are properly generated, and that corrective or preventative actions are identified and effectiveness checks successfully completed in a time frame consistent with Company policy.

     

    6.) Assist Management with external compliance assessments performed by third party auditors.

     

    7.) Assist the Manager with review of FDA warning letters to monitor for areas for compliance vulnerabilities.

     

    8.) Assure all Compliance related requests from customers, including Recovery Partners, are adequately addressed within requested timelines.

     

    9.) Execute all responsibilities with the highest degree of professional and ethical behavior.

     

    10.) Perform all other duties as assigned.

     

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

    Qualifications

    • Bachelor’s Degree, preferably in the Life Sciences, Engineering or an equivalent field of study.
    • Minimum of 2 years of experience performing CAPA investigations, documentation and performing effectiveness verifications of CAPAs.
    • Experience in FDA regulated industry required, specifically knowledge of applicable regulations, i.e. current Good Manufacturing Practices, Good Tissue Practices, Tissue Banking Regulations, Quality System Regulations, and ISO Standards.
    • Must have strong computer skills, i.e., word processing, spreadsheets, data analysis, etc.
    • Must exhibit strong and effective communication skills.
    • Must have excellent and effective writing skills.
    • Must be able to maintain a high activity level, and be able to effectively manage and prioritize numerous projects and responsibilities.
    • Must have the ability and willingness to travel 20% of the time.

    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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