1+ months
2018-03-212018-05-20

Software Development Quality Engineer II

Abbott
Los Angeles, 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.

Software Design Quality Engineer II is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development life cycle across Abbott.  Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Responsibilities:

  • Execute and support on-time completion of Design Control Deliverables
  • Support on-time execution of  Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Guides development and documentation of standard operating procedures, specifications and test procedures
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional  root-cause analysis investigation & resolution activities
  • Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection.
  • Reviews test protocols and test results provided by other functional group.   
  • Lead or support Risk Management activities from product Concept through Commercialization
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support internal & external audit responses
  • Support the establishment of objective, measurable, discrete, and verifiable  customer and product requirements
  • Complete Document Change Request Reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • 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:

    • Bachelor level degree in Engineering or Technical Field, advanced degree preferred.
    • 2-5 years experience
    • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
    • Experience working in a broader enterprise/cross-division business unit model preferred.
    • Ability to work in a highly matrixed and geographically diverse business environment.
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
    • Ability to leverage and/or engage others to accomplish projects.
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Multitasks, prioritizes and meets deadlines in timely manner.
    • Strong organizational and follow-up skills, as well as attention to detail.

      Preferred Qualifications:

      • 3-5 years experience in software testing, development and or validation
      • Programming knowledge in C/C#/Visual Studio/Java, Scripting Language such as Python, Perl
      • Working experience in Web Based and Mobile (iOS, Android) Application
      • Programming experience with test automation scripts   
      • Previous Software Quality engineering experience and demonstrated use of Quality tools/methodologies
      • Experience with software configuration, and issue tracking tools such as GIT, Subversion, ClearQuest, Doors, TortoiseHg, or Bugzilla.
      • Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485
        Job Family: Operations Quality
        Division: ASJM Abbott St. Jude Medical
        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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Software Development Quality Engineer II

Abbott
Los Angeles, CA

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Abbott
Los Angeles, CA
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