1+ months
2018-03-152018-05-02

Quality Technician II

Abbott
Irvine, CA

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support.

Responsibilities:

  • Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results.  Perform final product inspections against specification and procedural requirements.
  • Document nonconformances as appropriate.
  • Monitor and/or perform calibration and maintenance of all test equipment and fixtures.
  • Initiate related documentation changes.
  • Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
  • Collect data, summarize, and document test results.
  • Assist with or perform Gage R&R studies.
  • Assist with the selection, installation and programming of precision measuring equipment.
  • Create and maintain control plans for products and processes.
  • Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

    Qualifications:

    • High School degree required; 2 year technical degree preferred.
    • 2-4 years experience.
    • Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning.
    • Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
    • Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design.
    • Training in blueprint reading and experience with sampling techniques.
    • Good communication and computer skills, including data analysis and report writing skills.
    • Prior medical device experience preferred.
    • ASQ CQT certification or equivalent preferred.
      Job Family: Operations Quality
      Division: CAHF Cardiac Arrhythmias & Heart Failure
      Travel: Not specified
      Medical Surveillance: No
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Quality Technician II

Abbott
Irvine, CA

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Abbott
Irvine, CA
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