OSI Systems, Inc

  • Quality Systems Auditor 2

    Location US-WA-Snoqualmie
    Posted Date 2 months ago(1/23/2019 1:12 PM)
    Spacelabs Healthcare
    Requisition #
  • Overview

    At Spacelabs Healthcare, we are on a mission - to develop innovative medical systems and services that provide patient monitoring, anesthesia delivery and ventilation, and cardiology diagnostics to clinicians and healthcare facilities around the world.


    Our Mission: To inspire the world to bring the best care experience to patients and families. One patient, one family, one smile at a time.


    The Quality System Auditor is responsible to manage and perform Spacelabs Healthcare Quality  System internal audits to ensure compliance to company policies and procedures, as well as, external standards and regulations, including 21 CFR Parts 820, 803, and 806, ISO 13485:2016, Medical Device Directives (MDD), Medical Device Regulation (MDR) and other applicable standards and regulations.



    • Process owner for the Internal Audit program and associated procedures
    • Maintain and project manage updates to the Spacelabs Internal Audit program application
    • Perform conformity assessment audits of policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished
    • Create and maintain the Spacelabs Internal Audit Schedule and associated Work Plan
    • Coordinate activities of all Spacelabs Lead Auditors
    • Schedule, plan, and conduct internal audits
    • Communicate audit results through closing meetings, Management Review updates, and audit reports
    • Assist in managing CAPAs that result from Internal Audits; Provide feedback and guidance to CAPA Owners on corrective and preventive actions
    • Track implementation of corrective actions and perform effectiveness verification activities related to audit findings
    • Assist in coordinating and support external audits including interfacing with regulatory agencies such as FDA and TUV as required
    • Support CAPAs related to external audit findings
    • Conduct site planning and training in preparation of notified body audits and FDA inspections
    • Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork
    • Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct
    • It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem
    • Duties may be modified or assigned at any time to meet the needs of the business


    • A Bachelor’s degree in business or sciences, or 4+ years equivalent professional experience
    • 2+ years of experience as a Lead Auditor, or equivalent experience
    • 2+ years of experience in the medical device industry
    • ISO 13485 Lead Auditor certificate
    • Must be familiar with all elements of a Quality System, in particular the Corrective and Preventive Action sub-systems
    • Must be knowledgeable in FDA’s 21 CFR 820 and ISO 13485 requirements
    • Must have experience working with CAPAs, either by participating, owning or approving CAPAs
    • Must be reliable and capable of working with minimal supervision to manage audit planning, execution, and follow-up activities
    • FDA and Notified Body audit exposure is preferred
    • Extremely well organized and able to manage multiple assignments/tasks with varying deadlines and requirements
    • Considerable interpersonal skills are mandatory, including relationship-building skills, and strong presentation and communication skills
    • Excellent computer skills, including Microsoft Office, Outlook, Internet Explorer and web conferencing software


    Equal Opportunity Employer


    EEO is the Law


    Poster Link: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf


    OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for the Security and Healthcare divisions, as well as to external original equipment manufacturer clients for application in the defense, aerospace, medical and industrial markets, among others.



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