Abbott
Senior Manager, Quality Engineering - Informatics
Abbott, Lake Forest, Illinois, United States, 60045
Senior Manager, Software Quality and Cybersecurity
Informatics
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 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 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 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. 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. Job Family: Operations Quality
Division: CMI ARDx Cardiometabolic and Informatics
Location: United States > Lake Forest : J55
Additional Locations:
Work Shift: Standard
Travel: Yes, 10 % of the Time
Medical Surveillance: Not Applicable
Significant Work Activities: Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
Informatics
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 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 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 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. 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. Job Family: Operations Quality
Division: CMI ARDx Cardiometabolic and Informatics
Location: United States > Lake Forest : J55
Additional Locations:
Work Shift: Standard
Travel: Yes, 10 % of the Time
Medical Surveillance: Not Applicable
Significant Work Activities: Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.