Director, Quality Assurance

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 in 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 $338,700.00. In specific locations, the pay range may vary from the range posted.