ASQ Boulder

American Society of Quality Professionals

Quality Assurance Coordinator, Rocky Mountain Eye Bank, Aurora, CO

| Filed Under: Job Opportunities

General Information:

  • Company: Rocky Mountain Eye Bank http://www.corneas.org
  • JOB TITLE: Quality Assurance Coordinator
  • JOB CLASSIFICATION: Full-time, non-exempt
  • LOCATION OF POSITION: Aurora Office
  • THIS POSITION REPORTS TO: Quality Assurance Manager
  • SUMMARY STATEMENT:
    • The Quality Assurance Coordinator assures compliance with government and industry standards.
    • The Quality Assurance Coordinator monitors SOP/document forms, change control process, champions a continuous quality improvement process and may be the Eye Bank’s OSHA representative.

ASSIGNED RESPONSIBILITIES AND DUTIES:

  • Receiving and investigating departures, deviations and corrective actions
  • Follow-up and tracking corrective action effectiveness
  • As needed assist with SOP/document change control process
  • Assist with records retention control
  • Monitor equipment verification, maintenance, and cleaning records
  • Perform activities associated with inspections, audits, monitoring, and trending
  • Review / audit records and procedures for completeness, accuracy, and compliance
  • Activities associated with vendors and contracted service providers – agreements, off site audits
  • Review donor records for completeness, accuracy and data collection after distribution
  • Perform customer service tasks with current and potential surgeons
  • Assist with or conduct new surgeon orientation
  • Receive, investigate and evaluate information to include complaints and donor new information
  • Assist in managing adverse reactions/events and complaint trends
  • Follow-up and data entry of pending recipient information for transplanted tissues, including Recipient Information Forms and Recipient Post-operative Follow-up Forms
  • Provide feedback and training to technical staff related to chart completeness and accuracy
  • Provide new employee safety training
  • Assess organizational training needs as part of a team; design, coordinate and implement training programs
  • Assist in compiling, disseminating, and examining statistical data as directed
  • Complete Department of Health Serology Reporting.
  • Perform other duties as necessary and as assigned by management

QUALIFICATION REQUIREMENTS:

  • EDUCATION:
    • A Bachelor’s degree in a science related field is required.
    • Appropriate regulated industry experience or certification may be substituted for education.
    • Thorough knowledge of ocular anatomy and physiology as well as medical and medical terminology knowledge is needed to understand aspects of eye banking.
  • EXPERIENCE:
    • The Quality Assurance Coordinator should have at least 2 years experience working in a regulated industry.
    • Knowledge and experience with FDA regulations and quality systems (cGTP or cGMP) is a must.
    • An understanding of auditing practices and basic statistical analysis is needed.
    • Familiarity with EBAA or AATB medical standards is a plus.
    • The Coordinator should have experience working with quality systems / programs, preferably in eye or tissue banking, medical diagnostics, medical devices or other medical areas.
    • Consideration will be given to candidates with equivalent experience or knowledge from a cross-over profession or industry.
    • The Coordinator should be familiar with MS Office, donor databases and electronic quality databases.
    • The Coordinator is responsible for performing administrative aspects that may include interaction with or within the Technical, Quality, Public Relations and Accounting Departments.
    • The position requires excellent people skills, as well as effective written and verbal skills for both internal and external communication.
    • The Coordinator may be asked to develop and maintain business relationships with surgeons, surgery sites and their staff in an effort to open communication channels for reliable quality monitoring.
    • The specific training is provided by the managers of each department where applicable.

COMPENSATION:

  • Salary Range is dependent upon experience.
  • RMEB provides a full benefits package to include healthcare, dental, vision, 401k, holidays, paid time off and flexible scheduling.

Apply and More information

  • Resumes must be accompanied by a cover letter explaining how the applicant meets the job requirements and desired skills.
  • Please email cover letter and resumes to mailto:swolff@corneas.org with applicant name and the job title listing in the subject line.
  • note: The deadline for application submission is April 29, 2014.
  • No phone calls, please.