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Job

QA Technician

  • Job ref:

    8955

  • Location:

    Mansfield, United States

  • Sector:

    Quality Technicians

  • Contact:

    Brad McGovern

  • Published:

    22 days ago

QUALITY ASSURANCE TECHNICIAN

Overview:

Provide quality assurance support to the assigned program and/or area to ensure that the product is built in accordance with customer and division quality requirements while maintaining production flow

Specific Responsibilities:

  • Assist in the management of the company’s calibration and maintenance systems in accordance with regulatory requirements.
  • Assist with processing nonconformance reports, including the investigation for resolution.
  • Expedite nonconformance evaluation and disposition.
  • Conduct in-process and incoming inspection to approved procedures.
  • Assist in training of employees in new policies and procedures.
  • Determine acceptability of rework by inspection and/or test.
  • Perform packing line and manufacturing inspection.
  • Interpret manufacturing drawings, diagrams and specifications to approve or reject product or systems.
  • Apply appropriate approval or rejection labels to materials after data evaluation.
  • Review device history records and complete sterilization reports per approved procedures.
  • Supports the operations group while maintaining quality assurance policies and procedures
  • Performs other responsibilities associated with this position as may be appropriate.

Qualifications:

  • 4+ years in medical device quality assurance or related field
  • A working knowledge of industry practices and current technology is required, as well as computer literacy and proficiency in utilizing appropriate software.
  • A working knowledge of FDA Quality System and ISO 13485 regulations.
  • Requires a motivated individual that can work with minimal supervision.