JOB DESCRIPTION:
The Opportunity
Abbott’s Digital Solutions organization, part of the Medical Devices group, partners with our Diabetes, Cardiovascular, and Neuromodulation businesses to develop and commercialize digital technologies that expand access to care, optimize medical procedures, and improve chronic disease management. Together with Abbott’s life-changing medical devices, Digital Solutions leverages technologies such as AI and data interoperability to enable people to live life to the fullest.
We are seeking a Director, Quality Assurance to join our team and establish the QA function within Digital Solutions for a diverse and growing portfolio of digital health products, including software as a medical device (SaMD), connected devices, and digital health platforms. This position reports directly to the Division Vice President, Digital Solutions and will be instrumental Digital Solutions’ expansion and impact.
You will develop and implement a best-in-class Quality Management System (QMS) that supports both medical and non-medical digital products globally and is adaptable to emerging digital health technologies. You will also serve as the QA subject matter expert across all Digital Solutions programs, collaborating with global businesses and cross-functional teams and representing the voice of Quality in strategic decisions.
Key Responsibilities
Quality Assurance
- Develop, implement, and continuously improve a quality management system tailored for digital health innovation
- Define and execute the global QA strategy for Digital Solutions
- Ensure compliance with all applicable standards and regulations (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, EU MDR)
- Prepare for and lead audits
Strategic Leadership
- Act as the primary authority on quality matters related to digital technologies, including AI/ML, cloud platforms, and data interoperability
- Provide strategic input into product development, risk management, and lifecycle planning
- Represent QA in leadership discussions and strategic planning
People Leadership
- Partner across Abbott businesses and functions to educate and embed quality compliance throughout the product lifecycle
- Build and lead a high-performing and inclusive QA team aligned with Digital Solutions’ growth trajectory, fostering a culture of innovation, compliance, and continuous improvement
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field (Master’s or RAC certification preferred)
- 10+ years of progressive experience in Quality Assurance within the medical device or digital health industry
- Deep knowledge of global quality standards for digital health, SaMD, connected devices, MDDS, and multi-function products
- Proven leadership experience leading cross-functional teams
- Regulatory Affairs experience a plus
The base pay for this position is
$169,300.00 – $338,700.00In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:CHMN Office of the Chairman
LOCATION:United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:United States > Chicago : Willis Tower Building 233 S Wacker Dr., United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive, United States > Santa Clara : 4551 Great America Parkway
WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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
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What We Do
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 109,000 colleagues serve people in more than 160 countries.
