• Quality Excellence Expert - AV Access

    Job ID
    1845
    # of Openings
    1
    Job Type
    Full-Time
    Work Schedule
    Monday-Friday, 8am-5pm
    Job Category
    Humacyte
  • Overview

    For more than 20 years, AlloSource’s allografts have been the biologic solutions our surgeon customers use to deliver better care to their patients. As one of the largest and most respected nonprofit tissue banks in the United States, AlloSource develops, processes and distributes over 200 types of life-saving and life-enhancing allografts for use in a variety of medical procedures. Our commitment to honoring the gift of tissue donation motivates us to develop innovative allografts and lead the way in cellular and tissue therapies.

     

    Compliance Statement

    Must comply and ensure adherence with FDA, CGTP, OSHA, AlloSource SOPs, work instructions & procedures, proper practices and techniques, AATB standards, and applicable company policies, training requirements, safety practices and regulatory requirements that are applicable to the job responsibilities.

     

    Summary

    The Quality Excellence Expert – AV Access will serve as the department subject matter expert for specific processes within the quality system and AlloSource Excellence. Makes decisions based upon knowledge, training and experience, with regulatory compliance and the integrity of AlloSource at the forefront of consideration. Manages and maintains specific departmental quality system responses and contribute knowledge and expertise, specific to one or more assigned subject category(ies), in alignment with the Baldrige Performance Excellence Framework and AlloSource’s Enterprise Performance Excellence (EPEx) program, activities, and initiatives.

     

    Serving the department, this position will evaluate, recommend, and implement improvements for the department’s processes, based on standards & regulations, change controls, corrective & preventive actions, and process improvement projects. This position is responsible for drafting document revisions to the relevant documents, providing training to end users, encouraging and implementing process improvements, and providing periodic productivity and compliance reports to Management

     

    Essential Duties and Responsibilities:

    1.Quality System Responsibilities:

    1. Nonconformance Reports
    2. Change Control
    3. Complaints
    4. Participate in internal audits to ensure system processes are operating in accordance with controlled procedures.
    5. CAPA support

    2.Departmental Responsibility: Serve as departmental technical expert for a Quality Management System [QMS] processes.

    1. Is a central contact point for all Quality Management System personnel and provides support for the ongoing management of the QMS processes
    2. Address QMS system administrator questions promptly with a professional and courteous demeanor.
    3. Manage and maintain specified departmental related policies and procedures
      1. Confer with document owners and department managers to establish process set-up requirements and resolve discrepancies as needed.
      2. Procedure content coordination and revision support
    4. Provide periodic productivity and compliance reports to management, and compile/analyze data presented at   quarterly management review meetings.
    5. Manage and maintain department records/log books/log review

    3. Performance Excellence Responsibilities:

    1. Acquire and maintain working knowledge of Baldrige Framework
    2. Capture, Trend and Report Metrics
    3. Support Baldrige Category Leads and participate in Opportunities for Improvement projects
    4. Utilize PDSA/DMAIC improvement methodologies
    5. Create and maintain Business/Transactional process maps with control points
    6. Create and maintain non-technical value stream maps

     

    Requirements:

    • 5 years’ experience working in Production
    • Baldridge Framework training completed within one year of accepting role.
    • Successful completion of AATB Certification required within one year of accepting role. If already certified, evidence of certification.
    • Required Certifications:
      • CAPA
      • Root Cause Analysis
      • Value Stream Mapping
      • ASQ Quality Tools, Plan-Do-Study-Act plus Q Tools
      • Measuring Process and Organizational Performance
      • Improvement Tools & Techniques; Charts, Controls, Diagrams, Improvement Methods and Problem Solving
      • or successful completion of certification courses within one year of accepting position

     

    • 5 years’ working with quality records in a regulated industry.
    • 3 years’ experience writing/editing formal documents
    • Technical writing skills
    • Can provide specific examples where he/she has implemented improvements for department processes
    • Has demonstrated ability to train end users and end users have positively changed their business impact as a result of such training
    • Advanced proficiency in Microsoft Applications, specifically Excel, Word and Outlook.

     

    Preferred Experience:

    • Bachelor’s degree
    • AATB certification
    • Green Belt Certification
    • Quality Assurance/Regulatory Affairs position in a manufacturing or other technical environment
    • Experience with Pilgrim SmartSolve Quality Management System software

     

     

    For consideration you must apply online, submit a current resume and meet the minimum requirements. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.

     

    Equal Opportunity Employer/Veterans/Disability

     

    AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

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