Principle Professional Quality - Software

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 122,000 colleagues serve people in more than 160 countries.

     

• Serve as a quality subject matter expert for digital health solutions, providing guidance on quality, compliance, risk management, and software development best practices.

• Lead quality assurance efforts throughout the product lifecycle, including design reviews, risk assessments, verification and validation activities, change control, and product release.

• Collaborate with engineering, product management, and IT teams to ensure quality and security requirements are effectively integrated into design, development, and maintenance processes.

• Support post-market surveillance and customer feedback analysis to drive product improvements and ensure continued compliance.

• Oversee key quality system processes, including document control, nonconformance and CAPA management, and internal audits related to both product quality and information security.

• Maintain and continuously improve certified quality management system (ISO 9001, ISO 27001, etc.), ensuring alignment to divisional, corporate, and external requirements.

• Provide quality oversight of suppliers, contractors, and service providers to ensure compliance with established quality and information security requirements.

• Support and facilitate external and internal audits, certification assessments, customer audits, and regulatory inspections, ensuring organizational readiness and effective resolution of observations.

• Collaborate with global quality teams and technical teams in United States, Portugal, and Italy to drive harmonization, consistency, and continuous improvement across quality processes.

• May serve as the Management Representative for the Quality System; acts as a point of contact providing quality guidance and expertise for digital products to represent the organization as the main interface with necessary regulatory bodies and external auditors.

• Associate’s degree in engineering, quality assurance, or a related technical field.

• Minimum 3+ years of experience in quality assurance or quality control, preferably in product development, regulated environments, non-medical products, or digital health.

• Experience with ISO 9001 and ISO 27001 quality systems preferred.

• Familiarity with agile development, design control, risk management, and post-market surveillance processes.

• Bachelor’s degree in Software Engineering, Computer Science, Quality Engineering, Biomedical Engineering, Information Systems, or a related technical discipline.

• 6+ years of progressive Quality Assurance experience supporting software, digital health, diagnostics, medical devices, or other regulated product environments.

• Demonstrated ability to lead design reviews, risk assessments, root cause investigations, CAPA activities, and supplier quality management.

• Knowledge of software development methodologies, including Agile and Scrum, with familiarity in cybersecurity and information security principles, risk management frameworks, secure software development practices, and information security controls.

• Proven ability to independently manage multiple priorities, lead complex quality initiatives, and deliver results in a fast-paced, global environment with cross-functional teams, including engineering, product management, marketing, regulatory affairs, IT, cybersecurity, and suppliers.

• Strong communication, organizational, and problem-solving skills, with the ability to influence stakeholders and drive continuous improvement.

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Operations Quality

     

CRLB Core Lab

        

United States > Lake Forest : CP01

     

Standard

     

Yes, 10 % of the Time

     

Not Applicable

     

Continuous sitting for prolonged periods (more than 2 consecutive hours 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: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf