Abbott Software Quality Manager in St. Paul, Minnesota

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 Manager. This position will be responsible for managing the team ensuring compliance and execution of Software design and 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 SW projects activities

  • Compliance with SW development and validation SOP/WIs and participate in process improvement initiatives

  • Implement Resource and Time management tools to effectively manage resources, request lead times

  • Ensure clear ownership and commitments for resources and timelines for all SW project 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

  • Identify projected work intake through development of relationships with manufacturing and/or tool development

  • Maintain metrics for regular reporting and expand on metrics data

  • Maintain agreed upon request lead times and SLAs

  • 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.

Qualifications:

  • 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.).

  • 3-5 years of directly managing, leading, and working closely with software quality and automation engineers

  • Experience/knowledge of validation process and activities

  • Understanding of software impact manufacturing line, lab,)

  • Demonstrate leadership, strong problem-solving ability and action orientation when facing uncertainty

  • Demonstrated excellent written and verbal communication skills

  • Knowledge (well versed) of FDA and EU regulatory requirements for medical devices (FDA Part 820, 21 CFR Part 11, ISO13485:2016, SFDA, Japan, ANZ,, Brazil regulations, etc)

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

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com