1+ months

Software Quality Manager

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.

We are seeking an experienced, high caliber Software Quality and Validation Manager. This position will be responsible for managing the team ensuring compliance and execution of NPSW (Non-Product Software) validation policies and processes. As a manager, you will be working with motivated, diverse, and knowledgeable software quality engineers to deliver world-class products and results

Your responsibilities include:

  • Oversee and manage the operational aspects of ongoing NPSW validation activities
  • Ensure clear ownership and commitments for resources and timelines for all NPSW validation tasks
  • Develop mechanisms for monitoring project progress and for intervention and problem solving with software teams
  • Contribute to the growth and development of the software team related to validation best practices
  • Conduct and encourage frequent formal and informal communication within the team to ensure full engagement and efficient operation
  • Participate in continuous process improvement activities
  • 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.


    • Bachelor’s Degree in a technical discipline, preferably software related: Engineering, Computer Science, or Equivalent.
    • 7+ years of experience with a Bachelor’s Degree in a regulated industry (FDA, ISO, etc.).
    • 5+ years of experience with a Master’s Degree in a regulated industry (FDA, ISO, etc.).
    • 3-5 years of directly managing, leading, and working closely with software quality and automation engineers
    • Progressive experience in Non-Product Software Validation projects
    • Demonstrate leadership, strong problem-solving ability and action orientation when facing uncertainty
    • Demonstrated excellent written and verbal communication skills
    • Knowledge of FDA and EU regulatory requirements for medical devices

      Your preferred qualifications:

      • Ability to work in a highly matrixed and geographically diverse business environment.
      • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
      • Ability to work effectively within a team in a fast-paced changing environment.
      • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
      • Multi-tasks, prioritizes and meets deadlines in timely manner.

        Strong organizational, planning, and follow-up skills and ability to hold others accountable
        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 Quality Manager

Saint Paul, MN

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