30 days old
2018-03-192018-05-18

Software Development Quality Manager

Abbott
Saint Paul, MN

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.

Impact this role will have:

  • The Software Development Quality Manager works with the design assurance engineers to determine methods, techniques, and evaluation criteria for medical devices.
  • Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD/MDR requirements and solid understanding of the application of ISO 13485/14971 or IEC 62304 standards
  • Ensure compliance and provides guidance on FDA General Principles for Software Validation, Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and Postmarket Management of Cybersecurity in Medical Devices. 
  • Work with R&D, Operations, Enterprise, and Software V&V to ensure a development and test process, which complies with regulations and uses best practices to make an effective and efficient process. 
  • Identify potential compliance gaps and assess new regulations. Work with the departments to discuss how to apply best practices to meet regulations. 
  • Generate/approve/manage software and design verifications, design validations, test methods, and risk management documentation
  • Perform and guide risk management activities to drive collaborative discussions on appropriate mitigation strategies. 
  • Assigns and reviews project work of staff, sets work priorities, and reviews work.
  • Analyzes projects for resource requirements, and ensure resource availability to all projects.
  • Prepares overall project quality plans including milestones, validation processes and documentation procedures.
  • Conducts special analyses and projects as required.
  • Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
  • Responsible for budgeting/cost control, space and equipment acquisition, problem resolution, communication and policy implementation.
  • Hires and retains a diverse, highly qualified staff and provides coaching and ongoing performance feedback. Maintains a safe and professional work environment.
  • Performs other related duties and responsibilities, on occasion, as assigned.
    Job Family: Engineering
    Division: CAHF Cardiac Arrhythmias & Heart Failure
    Travel: Yes, 15 % of the Time
    Medical Surveillance: Not Applicable
    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 Manager

Abbott
Saint Paul, MN

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Abbott
Saint Paul, MN
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