Nonproduct SWQA Lead

JOB DESCRIPTION :
Working at Abbott

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.

Working 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.

This position works out of our Alameda, CA location in the Lingo Division.

Meet Lingo – a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers such as glucose, ketones, and lactate to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Personalized healthcare is the future. Working on Lingo you will help build a next‑generation technology that enables individuals to make decisions about how to improve energy, lose weight, or enhance athletic performance.

The Lingo team embodies a start‑up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.

This Nonproduct SWQA Lead is responsible for ensuring that computerized systems used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements. They help organize and maintain an inventory of software computerized systems and tools in use to ensure they are in a continued state of validation. They are a key contributor to validation efforts by reviewing quality system documentation as they apply to the development, verification, validation, use, and maintenance of the software or firmware.

They independently coordinate activities with other functions, departments, and contractors to complete validation activities. They may also train and direct the work of contractors to see projects through to completion.

• Provide Quality leadership in direct support of implementation and maintenance of the nonproduct software life cycles.
• Lead, oversee, or contribute to multiple portions of the Quality System, including but not limited to Master Validation Plans, Impact Assessments, Validation Plans, System Specifications, Requirements, Test Protocols, Test Reports, Trace Matrices, Summary reports, NC / CAPA and others as needed.
• Complete SWQA tasks in accordance with current Quality System Requirements.
• Work independently with objectives given by manager, planning and coordinating own work and work of others to high‑level project schedules.
• Review pre‑defined deliverables / activities as identified in the SWQA Non‑Product Quality Process Company Policies or project plans.
• Maintain schedules and drive to meet SWQA schedule as aligned with project(s) goals.
• Report unexpected events, issues or software bugs which occur during verification / validation to project team and management.
• Develop and maintain departmental operating procedures to ensure compliance with relevant FDA QSR ISO guidelines including 21 CFR Part 11 and Abbott Corporate requirements…