Software Design Quality Manager

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with a high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our San Diego, CA location. The business group this role resides in is the Abbott Rapid Diagnostics Infectious Disease team (ARDx ID). We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people

This website is an example of some of the division's products: ID NOW COVID-19 2.0 | Abbott Point of Care

What You’ll Work On

In this role, you will manage resources for the Software Quality department, set department goals, develop and maintain processes and procedures, and ensure adherence to the software development lifecycle across the division.

In addition:

Develop, maintain and oversee the divisional software development and validation program.

Develop and conduct training of company personnel for the divisional software development and validation program.

Work with Design and Manufacturing Engineering in the completion of system / software requirements and other verification and validation processes. 

Review and approve product software design history file deliverables, such as development plans, verification protocols and reports, and traceability matrices.

Develop and implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.

Assist in the completion and maintenance of risk analysis, focused on software related risks.

Develops and manages department operating budget.

Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Supervises one Quality Engineer.

Maintains a safe and professional work environment.

• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

• Ensure compliance to relevant FDA QSR, ISO guidelines, including IEC 62304 and 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems.

• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor's Degree or an equivalent combination of education and work experience