Software Quality Engineer, Cybersecurity Compliance

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 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Job Title

Software Quality Engineer, Cybersecurity Compliance

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 of which you dream.
• 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 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  

This position works at our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. 

This role is fully onsite.

What You’ll Work On

You will support software quality and cybersecurity compliance activities for medical device products by reviewing security alerts, tracking risk mitigation activities, and maintaining required quality documentation. Working closely with Product Development, Quality, and Cybersecurity teams, you will help ensure compliance with design controls, regulatory standards, and company quality processes.

MAIN RESPONSIBILITIES

• Support Quality Engineering deliverables throughout the product lifecycle, including ownership of risk management activities, including cybersecurity risk management.
• Support on-time execution of Quality Plans
• Guide development and documentation of standard operating procedures, specifications and test procedures
• Support product recertifications
• Review and document outputs from cybersecurity threat model analyses conducted by the Cybersecurity team, ensuring traceability and compliance with quality and design control requirements.
• Review, track, document, and facilitate resolution of product vulnerability notifications and cybersecurity alerts provided by the Cybersecurity team.
• CAPA management – including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria.
• Work within Agile software development lifecycle framework
• Support usability and human factors engineering reviews
• Coach and mentor team members on best practices in design quality, and overall product lifecycle testing/quality engineering to establish product and system reliability. Accent on agile testing and automated testing practices
• Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection
• Review and approve test methods, protocols and test results provided by another functional group.
• Support activities related to software change management and overall change management
• Bring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activities
• Support all activities, as needed by the business within the software development lifecycle.
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Support internal & external audit and related responses
• Support the establishment of objective, measurable and verifiable customer and product requirements
• Complete document Chan