Quality AI/ML Engineer I

Job Description

What Will You Do?

The Quality ML/AI Engineer is a highly technical and analytical role supporting the Quality organization and broader enterprise initiatives through the design, development, and deployment of advanced data, machine learning, and artificial intelligence solutions. This role focuses on building scalable and compliant analytical frameworks that connect Quality and business systems to enable proactive product monitoring, advanced quality metrics, improved decision-making, and operational efficiencies.

This position is responsible for developing and maintaining code-based analytical solutions, integrating data across GxP and non-GxP systems, and applying statistical, machine learning, and AI techniques to regulated data sets to support compliance, post-market surveillance, product performance monitoring, and continuous improvement initiatives. The role partners closely with Quality, Global Technology Services, Manufacturing/Operations, R&D, and cross-functional business stakeholders to ensure solutions are technically robust, scalable, and aligned with regulatory expectations.

How Will You Make an Impact?

Data Engineering, Architecture & Integration

• Design, develop, and maintain scalable data pipelines and integrations connecting Quality, Manufacturing, Post-Market, and enterprise systems such as QMS, ERP, PLM, CRM, complaint handling, and adverse event platforms.
• Develop and maintain production-ready analytical code using tools such as Python, SQL, R, or similar programming languages to support ETL/ELT processes and advanced analytics.
• Build scalable data models, repositories, and analytical frameworks that support cross-platform insights while maintaining data integrity, traceability, and compliance in regulated environments.
• Ensure data solutions align with data governance standards, computerized system compliance requirements, and validated system expectations.

Machine Learning & Artificial Intelligence Development

• Develop, validate, and maintain machine learning and AI models to support quality monitoring, operational efficiency, predictive analytics, and business insights.
• Apply statistical, machine learning, and AI methodologies based on business needs, data maturity, risk considerations, and intended use.
• Partner with Quality, Operations, and Regulatory stakeholders to define model intent, limitations, and appropriate application within Quality Management Systems and business operations.
• Build explainable, transparent, and scalable models suitable for regulated and non-regulated decision-support environments.
• Contribute to enterprise-wide ML/AI initiatives that drive innovation, automation, and continuous improvement across the organization.

Quality Metrics, Monitoring & Reporting

• Design and automate dashboards, reporting tools, and monitoring solutions using code-based and business intelligence platforms to provide near real-time visibility into product and system performance.
• Translate complex analytical outputs into clear, actionable insights for leadership, Management Review activities, and cross-functional teams.
• Continuously assess data quality, model effectiveness, and reporting relevance, refining analytical approaches as business and regulatory needs evolve.

Compliance, Validation & Risk-Based Assurance

• Ensure analytical tools, ML models, and AI solutions are developed and maintained in compliance with applicable Medical Device, Pharmaceutical, and Combination Product regulations.
• Support risk-based validation, change management, and documentation activities for analytical systems in accordance with internal procedures and regulatory expectations.
• Maintain documentation related to model design, assumptions, data sources, limitations, and ongoing performance monitoring appropriate for GxP environments.

Collaboration & Continuous Improvement

• Collaborate cross-functionally to translate business challenges into data-driven and AI-enabled solutions.
• Support investigations, audits, inspections, and regulatory interactions related to data integrity, quality metrics, and analytical systems.
• Identify opportunities to improve efficiency, increase automation, and reduce manual reporting efforts across the Quality organization and broader enterprise.
• Contribute to a collaborative, innovative, and continuous improvement-focused culture.

How Will You Get Here?

• Bachelor's degree in Computer Science, Data Science, Artificial Intelligence, Engineering, Life Sciences, Chemistry, or a related technical field.
• 1-2 years of experience in data science, analytics, machine learning, software-enabled analytics, or related technical roles, preferably within a regulated GxP environment.
• Hands-on experience developing and maintaining analytical or production code using tools such as Python, SQL, R, or similar programming languages.
• Experience building reports, analyzing data, and solving business problems through data-driven insights and automation.
• Exposure to machine learning and/or AI model development for business, operational, or quality-related applications.
• Experience integrating data across multiple enterprise systems and structured or unstructured data sources.
• Understanding of Medical Device, Pharmaceutical, and/or Combination Product quality systems, regulatory expectations, and computerized system assurance concepts.
• Knowledge of data integrity principles, validation approaches, and risk-based methodologies in regulated environments.
• Strong analytical, problem-solving, communication, documentation, and stakeholder collaboration skills, with the ability to work effectively in fast-paced cross-functional environments.
• Experience working with validated quality software, along with proficiency in Microsoft Office applications (Excel, Word, PowerPoint, Visio), and a self-motivated, detail-oriented approach with flexibility to support evolving business needs.

#GKOSUS

About Us

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.


Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.


Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.


Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.


All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.