Oxford Immunotec, Inc.

  • QA Specialist II

    Job Location US-MA-Norwood
    Posted Date 3 weeks ago(9/27/2018 9:29 AM)
    # of Openings
    Quality & Regulatory
  • Overview

    Oxford Immunotec, a leader in the diagnostics industry, is seeking a highly motivated Quality Assurance Specialist to join our Norwood operations team.  Our Quality organization ensures high caliber systems and processes are in place to comply with regulatory and lab standards.  The successful candidate to join this team will have a solid understanding of quality improvement initiatives to certify that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the company’s North American operations.  


    • Support the organization in monitoring of the compliance of laboratory testing, manufacturing, and clinical research and ensuring continued effectiveness of the QMS according to CLIA, CAP, HIPAA, GLP, GMP, and QSR requirements
    • Prepare, maintain, analyze and present metrics related to the quality systems
    • Conduct and/or support internal audits including, but not limited to: audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-up
    • Work to accomplish efficient and effective quality review/audit of: procedures, protocols, risk assessments, reports, IQ/OQ/PQ documents, validations, deviations, complaints, and non-conformances/CAPAs, or other quality records, and provide professional and objective feedback based on the results
    • Provide hands-on QA support and oversight to internal staff to ensure compliance to SOPs and regulatory requirements
    • Additional daily duties and project work, as required:
      • Non-conformance and CAPA: Participate in the tracking, trouble shooting, investigation and progression of corrective and preventive actions related to non-conforming product or deviations from approved processes.
      • Complaints: Participate in the logging and investigation of customer complaints.
      • Change Control: Review, provide quality insight and support change control process for procedures, methods, equipment, and computer systems.
      • Document Control: Facilitate process for new, revised, and obsoleted documents (policies, procedures, forms, templates, marketing materials, etc.) and ensure proper tracking for status.
      • Training: Conduct and/or support continuous quality training including, but not limited to: induction/orientation, ongoing quality training, and annual regulatory training requirements.
      • Equipment: Ensure that equipment maintenance and servicing is performed according to specifications and that all equipment is qualified for use appropriately.
      • Process Validation: Support validation of laboratory procedures, collect and analyze data, and perform routine document review and special audits.
      • Reporting: Organize reports and interdepartmental meetings as required.


    • Bachelor’s degree in a life science related field required
    • 3-5 years Quality experience, preferably in laboratory setting
    • Medical device experience a plus
    • Good working knowledge of Microsoft Office programs
    • Experienced in working to CAP/CLIA/GLP/GMP and Quality Management principles


    • Strong attention to detail and Quality commitment
    • High standards of mathematics and writing ability
    • Excellent problem solving skills
    • Successful history of being conscientious, thriving in high pressure work, and demonstrating strong initiative
    • Ability to communicate and interact positively and professionally with internal and external customers
    • Collaborate effectively and positively within department and all other company departments
    • Ability to work autonomously with minimal supervision
    • Regular attendance and timeliness is essential


    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.  Follow all company safety policies & other safety precautions within work area.


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