Lead Software Quality Engineer

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:

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Lead Software Quality Engineer position within the Toxicology Business Unit, based in Kansas City, MO, focuses on workplace drug and alcohol testing services. This role is responsible for ensuring the quality and compliance of both product and non-product software throughout the software development lifecycle. The engineer will work closely with cross-functional teams to develop, implement, and maintain software quality processes and standards, while also supervising software quality staff. This role is located onsite in Kansas City, MO and is not hybrid or remote

What You'll Work on

• Assures that the Workplace software systems are compliant with applicable Abbott policies and processes for product software design and development, non-product computerized system life cycle (SLC) process and secure lifecycle process (SLP).

• Ensures Workplace procedures are established for each SLC phase, i.e. planning, requirements analysis, design, construction and coding, testing and implementation, operations and maintenance, and retirement.

• Supports software verification and validation activities for new products/services and software changes in accordance with plans.  This includes, but is not limited to, review and approval of software test case protocols and reports, review of software development plans, and review of other system and software documentation.

• Participate in meetings to prioritize, review and/or approve of action plans for addressing issues captured in Incident/Problem/Defect Reports (IPDRs) during development.

• Reviews and approves system risk classification (SRC).

• Participate in technical and project reviews to ensure design plans, product design and deliverables related to product software are met.  Represent the quality assurance function for the review and approval of applicable software design outputs.  

• Support non-product software verification and validation by assessing the need for supporting protocols, reports and other documentation as required.

• Work within Agile software development lifecycle framework.

• Support usability and human factors engineering reviews.

• Support activities related to software change management and overall change management.

• Provide training and support to team members on Abbott software lifecycle and cybersecurity quality system policies and processes.

• Support product cybersecurity assessments in conjunction with a cross-functional team.

• Support internal/external audits and quality system improvement activities related to software quality.

• Ensure compliance with regulatory s