Senior Manager, Quality Engineering - Informatics

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.

Senior Manager, Software Quality and Cybersecurity - Informatics

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 student debt program, and 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

The Senior Manager, Software Quality and Cybersecurity - Informatics role will lead global software quality and cybersecurity for Informatics, ensuring compliance with regulatory standards and driving continuous improvement across software development, validation, and security practices. Collaborate cross-functionally to secure medical device and non-medical device software and IT systems, aligning with industry frameworks and regulatory requirements.

What You'll Work On

• Oversee software quality assurance and validation programs across software systems.
• Ensure compliance with global regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, ISO 27001, NIST 800-53).
• Provide strategic leadership for software quality and cybersecurity across both medical and non-medical device software platforms.
• Ensure robust Corrective and Preventive Action (CAPA) processes are in place and effectively executed to address systemic issues.
• Maintain audit readiness and lead internal and external audit execution, ensuring compliance with regulatory and corporate standards.
• Develop and implement secure software development lifecycle (SDLC) practices.
• Manage change control, defect tracking, and code control systems.
• Lead cybersecurity risk assessments and threat modeling for medical device software (including SxMD).
• Conduct vulnerability assessments, penetration testing, and coordinate remediation efforts.
• Monitor evolving cybersecurity threats and regulatory changes, updating internal policies and procedures.
• Collaborate with R&D, Regulatory, Systems Engineering, and other stakeholders to define and implement quality processes including cybersecurity and data integrity controls.
• Drive continuous improvement initiatives using Six Sigma, Lean, and data-driven methodologies.
• Develop and manage departmental budgets and staff performance.

Required Qualifications

• Bachelor's degree in Engineering (Software, Computer, Electrical, or related field).
• 10+ years of experience in software development and validation, with 5+ years in cybersecurity for medical devices.
• Proven expertise in regulated environments (medical devices, pharma, or healthcare IT).
• Strong knowledge of cybersecurity tools, secure coding practices, and cloud security.
• Exposure to threat modeling (STRIDE, OWASP), SIEM systems, and vulnerability management.
• Familiarity with HIPAA, GDPR, and FDA cybersecurity guidance.
• Excellent communication, leadership, and project management skills.
• Global operations experience preferred.

Leadership Expectations

• Oversee certification processes and ensure alignment with industry standards and regulatory requirements.
• Drive training compliance across the organization, ensuring all personnel are trained and qualified per their roles.
• Establish and monitor key performance indicators (KPIs) to measure and improve software quality and cybersecurity performance.
• Lead overall site Quality Management System (QMS) responsibilities, ensuring integration of software quality and cybersecurity into the broader QMS framework.

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.

Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.



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

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.

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The base pay for this position is $127,300.00 - $254,700.00. In specific locations, the pay range may vary from the range posted.