Senior Manager, Quality Engineering - Informatics
Senior Manager, Quality Engineering - Informatics
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$ 127300 - 254700
1 Vacancy
Job Description
JOB DESCRIPTION:
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. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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 Youll 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
- Bachelors 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.
Were 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 Abbotts 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.
Connect with us at on Facebook at and on Twitter @AbbottNews.
The base pay for this position is
$127300.00 $254700.00In 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.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Senior Manager
Employment Type
Full-Time
Key Skills
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