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, can be based in Kansas City, MO, Lake Forest, IL or Richmond, VA. 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 standards (e.g., DOT, FDA, ISO 13485, IEC 62304, as applicable).

• Provides recommendations on process improvements as well as serve as the technical lead on software related CAPA investigations to identify root causes.

• Provides guidance with respect to applicable complaint investigation processes, and ensures compliance with regulations with respect to investigations.

• Follows through on project goals; provides knowledge and accountability to benefit the objectives of the business, e.g. participates in team meetings; serves either as functional subject matter expert or independent technical expert.

• Anticipates future direction and adjusts current processes accordingly.

• Work closely with Software Developers and Applications Support to prevent non-conformities and provide solutions to complex issues.

• Lead and support multiple projects, balancing priorities and resources to meet project and management expectations.

• Review and approve proposed changes for on market software by performing risk assessments, providing guidance and support and assessing the adequacy of verifications and validations and software design documents.

• Lead process improvement projects.

• Carries out duties in compliance with established business policies.

• Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.

Required Qualifications

• Bachelor’s degree in computer science, software engineering, or a related technical field.

• 5+ years of experience in software quality assurance or software development, preferably in the medical device/IVD industry.

• Advanced computer skills, including statistical/data analysis and report writing.

• Strong knowledge of software development life cycle (SDLC) and software testing methodologies.

• Experience with automated testing tools (e.g. Jira, JAMA, Azure DevOps) and techniques.

• Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports).

• Strong project management skills and able to multi-task and set priorities to meet overall business objectives.

• Excellent problem-solving and analytical skills.

• Ability to lead, coach, and mentor QA and IT personnel.

Preferred Qualifications

• Master's degree in a related field.

• Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles.

• Knowledge of FDA 21 CFR part 820 (US FDA Quality Systems Regulation), 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ISO 13485.

• 2+ years supervisory experience preferred.

• Advanced Information Technology and data mining skills.

• Certification in software quality assurance (e.g., CSQE, CSQA, CMSQ, CAST).

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.