• Quality Assurance Specialist II

    Posted Date 2 weeks ago(10/1/2018 3:23 PM)
    Job ID
    2018-2041
    Job Location
    US-GA-Kennesaw
    # of Openings
    1
    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

    Establish and maintain Quality Systems that comply with regulations and standards.  Review all records associated with the production of medical device products and make final decisions to release product.  Exercise discretion to reduce waste and variability in processes.   Initiate and provide consultation to management for cause-identification and problem-resolution for various types of quality investigations. Ensure that all areas identified as “Principal Responsibilities” are accomplished in an efficient and professional manner.

    Responsibilities

    • Complete all associated medical device production record reviews and make final decisions to release product based on review and discretion.
    • Increase productivity and revenues by optimizing processes and work flows through experience and knowledge obtained.
    • Initiate and provide consultation to management for cause-identification and problem-resolution for various types of quality investigations.
    • Working with management to formulate and using authority to implement new operating practices to improve processes.
    • Using your judgement, interface with other department personnel to clarify, collaborate, and/or correct the information provided, and to solicit required information.
    • Review all associated monitoring records for medical device production departments.
    • Generate Quality certificates for finished devices as required from Customer Service or Regulatory
    • Maintain Quality records.
    • Support and assist with other department’s projects, documentation requirements, or other needs that are required of Quality Assurance.
    • Develop systematic methods for completing work assignments to ensure deadlines are met and personal job commitments are accomplished.
    • Perform investigations for customer complaints.
    • Assist management with training functions as deemed necessary.
    • Provide input to management that facilitates the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job.  Initiate change requests and change orders.
    • Effectively complete “other” functions that may be assigned by management.

     

    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 in the Life Sciences or other scientific field or equivalent work experience.
    • Minimum 2 years’ experience in Quality preferred.
    • Previous experience in a regulated industry is preferred.

    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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