Senior Manager, Quality Engineering - Informatics

Senior Manager, Software Quality And Cybersecurity – 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.

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.
• Provide strategic leadership for software quality and cybersecurity.
• Ensure robust Corrective and Preventive Action processes are in place.
• Maintain audit readiness and lead internal and external audit execution.
• Develop and implement secure software development lifecycle practices.
• Manage change control, defect tracking, and code control systems.
• Lead cybersecurity risk assessments and threat modeling.
• Conduct vulnerability assessments, penetration testing, and coordinate remediation efforts.
• Monitor evolving cybersecurity threats and regulatory changes.
• Collaborate with R&D, Regulatory, Systems Engineering, and other stakeholders.
• Drive continuous improvement initiatives.
• Develop and manage departmental budgets and staff performance.

Required Qualifications

• Bachelor’s degree in Engineering
• 10+ years of experience in software development and validation
• Proven expertise in regulated environments
• Strong knowledge of cybersecurity tools, secure coding practices, and cloud security
• Exposure to threat modeling, 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
• Drive training compliance
• Establish and monitor key performance indicators
• Lead overall site Quality Management System responsibilities

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.

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.