QA Tech

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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QA Tech

  • Specialty:

    Engineering
  • Title:

    QA Tech
    • City:

      Watertown
    • State:

      MA
    • Zip Code:

      02472
  • Start date:

    04-17-2018
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    45140

Description

Our client located in Watertown, Ma is looking for a Quality Assurance Technician to join their first shift on a 6+ month contract assignment. This position offers flexible hours with overtime.

Quality Assurance Technician

General Requirements

  • Highly flexible work hours and work days
  • Organization skills are required
  • Computer skills are required (MS Office Suite of Products)
  • Detailed oriented and can follow instructions

Responsibilities

  • Equipment calibration-maintain database, schedule calibration with external vendors, review calibration reports, if needed start investigation into equipment calibration failures
  • Preventive Maintenance-maintain database and paper logs, ensure completion of scheduled PM, perform PM if needed
  • Training-maintain the database and organize paper files and conduct periodic reviews of records for completeness and accuracy
  • Document Control-process and file document change orders
  • CAPA Verification of Effectiveness-assist or perform as needed
  • Environmental Monitoring of Clean Rooms-schedule and review paperwork
  • Equipment IQ/OQ-review, help execute, and approve
  • Clinical inventory-handle shipping and internal inventory with project engineer
  • Lab notebooks-issue and archive lab notebook and review periodically for compliance to internal procedure
  • Order standards and regulations and maintain/update the log
  • Approved Vendor List-review and maintain/update the AVL as needed
  • Management Review-support the preparation of material for management review
  • Ensure adherence to company quality assurance procedures and applicable US and Outside the US regulatory requirements and guidelines.

Requirements

  • BS or Associated degree in Engineering or related scientific discipline
  • 1-3 years’ experience in Quality Assurance in medical devices, pharmaceuticals, or combination products
  • Experience with ISO 13485 and GMP CFR 820 and 210/211 is preferred
  • Working knowledge of the US and International standards governing the design, development and manufacture of medical devices
  • Excellent computer (MS Office), written and verbal skills

 

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