Sr. Quality Analyst, Data Analytics & Automation

Baxter International Inc.•Skaneateles, NY

1d•$88,000 - $121,000•Hybrid

About The Position

The Sr. Quality Analyst, Data Analytics & Automation is responsible for leading strategic quality data and digital automation projects within the site and organization to drive continuous improvement while ensuring compliance with regulatory requirements and alignment with business objectives. This role partners cross-functionally to execute quality technical projects that enable operational excellence and on-time implementation. This role is critical in our commitment to continuously improving the quality of our products, maintaining compliance and delivering safe and effective products to our customers.

Requirements

Bachelor’s degree required.
3+ years of experience in quality assurance, manufacturing operations, data analytics or project execution in a regulated industry.
Experience with statistical process control (SPC) and Six Sigma methodologies.
Experience leading projects from concept to implementation & closure.
Experience working with automation tools required.
Experience with Quality Management Systems: Experience with quality management systems, including experience in implementing and maintaining QMS.
Strong knowledge of quality management systems (e.g., ISO 13485, FDA QSR) and regulatory requirements.
Proven experience in leading improvement projects and cross-functional collaboration.
Excellent analytical and problem-solving skills, with the ability to interpret complex data and make data-driven decisions.
Strong communication and interpersonal skills, with the ability to influence and collaborate effectively across departments.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and quality management software.
Experience and knowledge with Power BI, Tableau and other data automation tools.

Nice To Haves

Exposure to AI/ML applications, predictive analytics, or intelligent automation is a plus.

Responsibilities

Develop and maintain dashboards, visualizations, and automated reporting solutions using Power BI, Tableau, Excel, and other business intelligence tools to meet business requirements.
Analyze quality data to identify trends, support investigations, drive root cause analysis, and improve process performance.
Develop automated workflows and reporting tools to improve efficiency, data integrity, and visibility across Quality System processes.
Leverage advanced analytics, machine learning, and generative AI solutions to enhance quality system monitoring, forecasting, decision-making, and process automation.
Partner with cross-functional teams to drive data-driven continuous improvement while ensuring data governance and regulatory compliance.
Support Management Review, KPI reporting, audit readiness, and regulatory reporting activities
Lead, manage and implement strategic technical quality projects that improve operational efficiency, compliance, and business performance – from planning, execution and closure.
Lead Kaizen events to drive continuous improvement within complaint management and investigation of workflows.
Identify systemic issues through complaint and non-conformance trending data.
Ensure that QMS is compliant with regulatory requirements, including FDA, ISO 13485, and other relevant regulations.
Communicate effectively with all collaborators, including employees, management, and regulatory agencies, to ensure that all quality systems are properly implemented and maintained.
Employees at every level are responsible for quality (GMP) Good Manufacturing Processes and regulatory performance in the department to ensure quality programs are met.
Ensure compliance with FDA, ISO and other government regulations, legal documents and safety and ethical standards, obtaining legal compliance training.