• MedAccred Sterilization Engineer and Auditor

    ID
    2018-1161
  • Overview

     

    This contracted position is responsible for administering and guiding the MedAccred program Sterilization task group; developing audit criteria and state of the art consensus qualification procedures; auditing Sterilization Supplier sites; recruiting and training qualified auditors; scheduling pilot audits of suppliers using available and contracted resources; publishing audit/survey reports working through committee structure and due process to serve industry, government and society.  This position also supports implementation of the MedAccred program strategy and continuous improvement initiatives.  This remote work from home position requires some travel.  

    Responsibilities

     

    • Manage technical audit report generation/assessment with strict confidentiality and compliance with procedural and regulatory requirements; conduct technical audits as required; review/update audit reports; follow up and close non-conformances; ensure effective closure of audit reports for timely issuance of certificates solving conformance issues; provide technical summary reports to the assigned task group; provide required alerts in eAuditNet.
    • Manage assigned personnel including consultants (technical auditors)
    • Motivate and guide Industry Managed Committee and/or Task Groups activities in developing standards, manuals, and reviewing audit reports including planning; recruiting qualified technical volunteers; monitoring/managing results
    • Develop and Manage budgets of assigned activities
    • Audit sterilization supplier sites
    • Recommend process improvements for assigned programs and PRI. Identify gaps/problems and report to appropriate management 

    Qualifications

    • Four Year Degree in Engineering or Biological Sciences or Other Science Related Curriculum required
    • Mastery knowledge of ISO 13485, FDA 21 CFR Part 820 ISO 11135, ISO 11137-1and Sterilization Principles
    • 5+ years’ experience working in the medical device or related industry, required.
    • Minimum of 3 years hands-on sterilization work experience in Ethylene Oxide and/or Radiation (Gamma and/or Electron Beam)
    • Minimum of 5 years auditing experience, sterilization auditing experience preferred
    • Quality Assurance System experience (primarily ISO 13485 or 21CFR820)
    • Experience with Statistical Process Control and Process Validation
    • Excellent oral and written communication skills
    • Computer and Internet connection required
    • Computer skills with working knowledge of Microsoft Word, Excel and PowerPoint
    • Ability to travel 30% (Preferred) of the time
    • Ability to work for long periods at a computer/desk

     

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