CryoLife

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Quality Operations Director

at CryoLife

Posted: 3/16/2019
Job Reference #: 2119

Job Description

  • Posted Date2 months ago(2/6/2019 5:31 PM)
    Job ID
    2019-2119
    Job Location
    US-TX-Austin
    # 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

    The Director is responsible for the development and maintenance of the On-X LTI quality system in accordance with the EU Medical Device Directive (93/42 EEC), ISO 13485, CMDR and 21CFR820. Additionally, the person in this position is responsible for acting as the Management Representative for the Austin site. #linkedin

    Responsibilities

    • Plan, develop and maintain the ONXLTI quality system consistent with regulatory requirements and company needs.
    • Supervise employees in the Quality department to effectively administer all quality functions.
    • Coordinate with and support Engineering, Manufacturing and Quality Control functions in the interpretation and implementation of the quality system requirements.
    • Establish and maintain an internal audit process to ensure the effectiveness and compliance of the quality system.
    • Assure proper processing of product returns for potential quality issues or complaints.
    • Establish effective controls and staffing to support the manufacturing objectives.
    • Detailed responsibilities include the administration of: quality system training, quality planning, ensure process and software validations, supplier controls, calibrations, ensure control of nonconforming material, quality review of policies, procedures, and product documentation, ensure corrective and preventive action, archival and control of all company documentation, management review and implementation of risk management requirements of ISO 14971.
    • Coordinate with R&D to ensure compliance in the following areas:
      • design control process for new product development,
      • design control process for sustaining engineering
      • disposition of nonconforming material.
    • Serve as the Management Representative for the site.
    • Prepare and present Quality metrics per ISO & company standards
    • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
    • Remain on the forefront of emerging industry practices.

    Qualifications

    • BS degree in one of the physical sciences or engineering
    • ASQ Certified Quality Engineer (CQE) or Certified Quality Manager (CQM) is preferred
    • Green (black) belt or Lean Manufacturing experience is preferred
    • Experience and capability in performing all essential functions of this position
    • Strong interpersonal and communication skills.
    • Ability to define problems, collect & interpret data, and determine quality strategy.
    • Ten years manufacturing and quality experience in the medical device field including supervisory duties
    • Proficient in requirements of 93/42 EEC, ISO 13485, and 21CFR820
    • Working knowledge of Usability Engineering (EN 62366)
    • Adheres to an appropriate and effective set of core values
    • Establishes a strong leadership for the site and provides career development for the Quality team.
    • Willing to make appropriate decisions using a risk-based analysis
    • Manages a diverse team of Quality professionals
    • Good working knowledge of employment laws
    • Ability to read, analyze, and interpret written instructions
    • Required to read, write and speak English with good command of the language, follow verbal and written instructions and incorporate math skills into day to day operations
    • Travel for the position is estimated to be <25%.

    Company Info

    Who We Are.

    CryoLife is one of the world’s leading contemporary medical device companies whose technology and products bring restoration and hope to people all around the world. With a variety of innovative products and technologies available, including preserved human cardiac and vascular tissues, surgical adhesives and sealants, and mechanical heart valves, our mission is to restore the health of patients by delivering innovative technologies of unsurpassed quality. Since our inception in 1984, it is estimated that our products and tissues have been implanted in over 1 million patients worldwide. Headquartered in Kennesaw, Georgia, CryoLife employs over one thousand people from various education and experiential backgrounds across the United States and internationally.

    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.