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    Quality Engineer II - Salt Lake City, United States - Myriad Genetics

    Myriad Genetics
    Myriad Genetics Salt Lake City, United States

    1 week ago

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    Description
    Responsibility

    The Quality Engineer (QA - Quality Systems) will assist the Quality Manager (Quality Systems) with activities in support of Myriad's Quality Management System (QMS).

    Each employee's specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows:


    Operationalize the various programs which support the quality management system (QMS) including but not limited to: nonconformance/CAPA, Change Control, Proficiency Testing, Complaint Handling.


    Complete quality approvals and acceptance activities for nonconformances, change controls, finished reagents, policies, procedures, equipment qualifications, and other documents in support of the QMS.

    Provide quality and regulatory guidance and feedback for production, manufacturing, and other customers or users of the QMS.


    With direction from the Quality Manager, develop, maintain, and continuously improve the framework of the QMS, supporting the Quality Improvement Project List and Quality Objectives.


    Promptly respond to and investigate quality questions, complaints, incidents, and nonconformances and assist supervisors with the development and implementation of appropriate corrective action plans.

    Present QMS data and information to management, including during Management Review meetings.

    Work as part of a team to facilitate external audits and inspections.

    Assist the Quality Manager in responding to external audit findings and deficiencies and to internally resolve these issues with appropriate documentation.

    Receive and respond to internal audit findings. Work with internal customers to resolve internal audit findings with appropriate documentation.

    Continually improve knowledge of relevant quality/regulatory topics and changes.

    Additional duties as assigned.

    Qualifications

    Qualifications vary depending on the level of the Quality Engineer (I, II, III, IV, or V) as outlined in DPT 026, Quality Engineer Job Levels.


    At a minimum, qualifications include the following:
    Bachelor's degree in Engineering, Life Science, other technical discipline or equivalent experience.

    Related professional experience of 0-3 years.

    Physical Requirements


    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

    While performing the duties of this job, the employee is frequently required to sit; talk; or hear.

    The employee is occasionally required to stand; walk; use hands to finger, handle or feel; reach with hands and arms; and stoop; kneel; or crouch.

    The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and depth perception.

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