Oxford Immunotec, Inc.

  • Quality Manager

    Job Location US-TN-Memphis
    Posted Date 1 month ago(1 month ago)
    ID
    2018-1950
    # of Openings
    1
    Department
    QA/QC
  • Overview

    Oxford Immunotec is seeking a highly motivated and self-directed leader to join a cohesive Quality Assurance team in a high-volume clinical diagnostic laboratory.  The successful candidate will be responsible for providing Quality guidance to the lab operations team, ensuring the lab is compliant with relevant standards and regulations from CAP, CLIA, and states, and ensuring the Quality Management System is effective.  In addition, the successful candidate will develop and oversee a team of dedicated Quality professionals.

    Responsibilities

    • Elevate the Quality profile of the organization by engaging in meaningful dialogue with Operational partners
    • Serve our patients and clients by ensuring we provide test results of the highest quality and reliability
    • Provide support and oversight to the Quality team in such tasks as
      • Validation reviews
      • Non-conformance management
      • Risk assessments
      • Release of incoming and manufactured goods
      • Internal and supplier audits
      • New hire induction
      • Document Control
      • Training and Competency oversight
    • Host inspections by regulating and accrediting bodies
    • Create and report relevant quality metrics
    • Collaborate with cross-functional teams in the development of new products and services
    • Contribute to the organizational mission by partnering with other leaders and supporting them in their objectives

    Qualifications

    • Biological Sciences (or related) degree
    • 7+ years Quality experience, preferably in laboratory or IVD/medical device environment with 3 years of supervisory experience
    • ASQ Certified Quality Auditor (CQA), with experience performing internal and external audits
    • Experienced in working to GXP and a good knowledge of Quality Management principles
    • Strong attention to detail and Quality commitment
    • High standards of mathematics, writing ability and oral communication
    • Conscientious, thrives in high pressure work, and demonstrates strong initiative
    • Understanding of the scientific, biological and technical issues involved in developing diagnostic assays
    • Proficient in MS Office products

    PHYSICAL DEMANDS:  

    The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers.  Minimal travel required including international travel. 

     

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